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TOBA II BTK: Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries

Sponsor
Philips Clinical & Medical Affairs Global (Industry)
Overall Status
Completed
CT.gov ID
NCT02942966
Collaborator
(none)
233
Enrollment
49
Locations
1
Arm
59
Actual Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

Condition or Disease Intervention/Treatment Phase
  • Device: Tack Endovascular System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
233 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®
Actual Study Start Date :
Feb 8, 2017
Actual Primary Completion Date :
Jul 11, 2019
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tack Implant

Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.

Device: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
Other Names:
  • Post-PTA Dissection Repair Implant
  • Tack Implant
  • Tack Dissection Repair Device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days [6 months]

      Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.

    2. Safety - Number of Participants With MALE Plus POD at 30 Days [30 days]

      Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days

    Secondary Outcome Measures

    1. Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months [6 months]

      Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.

    2. Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months [6 months]

      Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males or non-pregnant females ≥ 18 years of age at the time of consent

    • Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception (abstinence is acceptable) through the duration of the study

    • Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the informed consent form (ICF), an impartial witness may sign on behalf of the subject

    • Willing to comply with all required follow-up visits

    • Rutherford Classification 4 or 5.

    • WIfI Wound grade of 0, 1 or modified 2.

    • WIfI Foot Infection grade of 0 or 1.

    • Estimated life expectancy ≥1 year

    Exclusion Criteria:

    • Is pregnant or refuses to use contraception through the duration of the study

    • Previous bypass graft in the target limb

    • Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure

    • Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements)

    • WIfI Foot Infection grade 2 or 3

    • Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile state

    • Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure

    • Existing stent implant in the target vessel

    • Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after the index procedure

    • Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter

    • WIfI Wound grade of 2 or 3.

    • Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated

    • Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure

    • History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure

    • Currently on dialysis

    • Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)

    • Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s)

    • Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments

    • Known hypersensitivity or allergy to contrast agents that cannot be medically managed

    • Subject already enrolled into this study

    • Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yuma Regional Medical Center Yuma Arizona United States 85364
    2 Mission Cardiovascular Research Institute Fremont California United States 94538
    3 Denver VA Medical Center Denver Colorado United States 80220
    4 Yale New Haven Hospital New Haven Connecticut United States 06510
    5 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    6 First Coast Cardiovascular Institute Jacksonville Florida United States 32256
    7 Piedmont Heart Institute Atlanta Georgia United States 30309
    8 Amita Health Cardiovascular Associates Elk Grove Village Illinois United States 60007
    9 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
    10 Midwest Cardiovascular Research Foundation Davenport Iowa United States 52803
    11 Cardiovascular Institute of the South Houma Louisiana United States 70360
    12 Ascension St. John Hospital Detroit Michigan United States 48215
    13 Michigan Vascular Center Flint Michigan United States 48507
    14 St. Louis Heart & Vascular Saint Louis Missouri United States 63136
    15 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
    16 Holy Name Medical Center Teaneck New Jersey United States 07666
    17 New Mexico Heart Institute, PA Albuquerque New Mexico United States 87102
    18 Novant Health Heart and Vascular Institute Matthews North Carolina United States 28204
    19 Rex Hospital Raleigh North Carolina United States 27607
    20 WakeMed Hospital Raleigh North Carolina United States 27609
    21 Lindner Research Center Cincinnati Ohio United States 45219
    22 University Hospitals, Cleveland Medical Center Cleveland Ohio United States 44106
    23 Ohio Health Research Institute Columbus Ohio United States 43214
    24 Einstein Healthcare Network Philadelphia Pennsylvania United States 19141
    25 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    26 The Miriam Hospital Providence Rhode Island United States 02906
    27 Palmetto Health USC Medical Group Columbia South Carolina United States 29203
    28 Kore Cardiovascular Research Jackson Tennessee United States 38305
    29 Centennial Medical Center Nashville Tennessee United States 37203
    30 University of Texas Medical Branch at Galveston Galveston Texas United States 77555
    31 Baylor College of Medicine Houston Texas United States 77030
    32 North Dallas Research Associates McKinney Texas United States 75069
    33 Mission Research Institute New Braunfels Texas United States 78130
    34 The Heart Hospital Baylor Plano Plano Texas United States 75093
    35 Cardiovascular Associates of East Texas Tyler Texas United States 75701
    36 Sentara Vascular Specialists Norfolk Virginia United States 23507
    37 Lake Washington Vascular, PLLC Bellevue Washington United States 98004
    38 Division of Angiology, Medical University Graz Graz Austria 8036
    39 St. Anne's University Hospital Brno Brno Czechia
    40 Karolinen-Hospital Arnsberg Germany 59759
    41 Franziskus-Hospital Berlin-Radiology Berlin Germany 10787
    42 Westküstenklinikum Heide Heide Germany 25746
    43 Universitätsklinikum Leipzig Leipzig Germany 04103
    44 Evangelisches Krankenhaus Mülheim an der Ruhr Mülheim an der Ruhr Germany
    45 Krankenhaus Buchholz Nordheide Germany 21244
    46 MEDINOS Kliniken des Landkreises Sonneberg GmbH Sonneberg Germany 96515
    47 Heart & Vascular Center - Semmelweis University Budapest Hungary 1122
    48 Bács-Kiskun County Hospital Kecskemét Hungary
    49 Auckland Hospital Auckland New Zealand 1023

    Sponsors and Collaborators

    • Philips Clinical & Medical Affairs Global

    Investigators

    • Principal Investigator: Patrick J. Geraghty, MD, Washington University School of Medicine in St. Louis
    • Principal Investigator: George Adams, MD, Rex Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Philips Clinical & Medical Affairs Global
    ClinicalTrials.gov Identifier:
    NCT02942966
    Other Study ID Numbers:
    • CA 0137
    First Posted:
    Oct 24, 2016
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Philips Clinical & Medical Affairs Global
    Angioplasty
    Below the Knee
    PAD
    Critical Limb Ischemia
    Lesion
    Claudication
    Additional relevant MeSH terms:
    Peripheral Arterial Disease
    Peripheral Vascular Diseases

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    Period Title: Overall Study
    STARTED 233
    COMPLETED 205
    NOT COMPLETED 28

    Baseline Characteristics

    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    Overall Participants 233
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    74.4
    (10)
    Sex: Female, Male (Count of Participants)
    Female
    76
    32.6%
    Male
    157
    67.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.4%
    Asian
    3
    1.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    39
    16.7%
    White
    187
    80.3%
    More than one race
    0
    0%
    Unknown or Not Reported
    3
    1.3%
    BMI (Kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kg/m^2]
    28.8
    (5.6)
    BMI >= 30 (Count of Participants)
    Count of Participants [Participants]
    86
    36.9%
    ABI in treated limb (ratio) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ratio]
    0.74
    (0.27)
    TBI in treated limb (ratio) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ratio]
    0.43
    (0.23)
    Rutherford Classification (Count of Participants)
    0
    0
    0%
    1
    0
    0%
    2
    0
    0%
    3
    38
    16.3%
    4
    78
    33.5%
    5
    117
    50.2%
    6
    0
    0%
    Wound Grade (Count of Participants)
    0
    122
    52.4%
    1
    91
    39.1%
    modified 2
    20
    8.6%
    2
    0
    0%
    3
    0
    0%
    Ischemia Grade (Count of Participants)
    0
    115
    49.4%
    1
    55
    23.6%
    2
    28
    12%
    3
    23
    9.9%
    Foot Infection Grade (Count of Participants)
    0
    194
    83.3%
    1
    39
    16.7%
    2
    0
    0%
    3
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
    Description Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    The number of evaluable subjects for the 6 Month Primacy Efficacy Endpoint was 209.
    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    Measure Participants 209
    Count of Participants [Participants]
    200
    85.8%
    2. Primary Outcome
    Title Safety - Number of Participants With MALE Plus POD at 30 Days
    Description Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Four subjects were not evaluable for the 30 Day primary safety endpoint due to missing the 30 day visit and no additional visits occurred beyond day 30. One subject was not evaluable for the 30 Day primary safety endpoint due to an early 30 day visit and no additional visits Day 30. These subjects were therefore not included in the denominator for the primary safety endpoint analysis.
    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    Measure Participants 228
    Count of Participants [Participants]
    3
    1.3%
    3. Secondary Outcome
    Title Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
    Description Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Some subjects had Tack implants placed in multiple lesions
    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    Measure Participants 233
    Measure number of lesions 303
    Number [number of lesions]
    248
    4. Secondary Outcome
    Title Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
    Description Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    The number of evaluable subjects for Target Limb Salvage at 6 Months was 209.
    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    Measure Participants 209
    Count of Participants [Participants]
    206
    88.4%

    Adverse Events

    Time Frame Summary of adverse events that have been reported through 210 days
    Adverse Event Reporting Description
    Arm/Group Title Tack Endovascular System (4F)
    Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
    All Cause Mortality
    Tack Endovascular System (4F)
    Affected / at Risk (%) # Events
    Total 63/233 (27%)
    Serious Adverse Events
    Tack Endovascular System (4F)
    Affected / at Risk (%) # Events
    Total 179/233 (76.8%)
    Blood and lymphatic system disorders
    Anemia 4/233 (1.7%) 4
    Microcytic anemia 1/233 (0.4%) 1
    Cardiac disorders
    Acute on chronic heart failure 2/233 (0.9%) 3
    Angina at rest 1/233 (0.4%) 1
    Angina pectoris 1/233 (0.4%) 1
    Aortic valve stenosis 2/233 (0.9%) 2
    Atrial fibrillation 1/233 (0.4%) 1
    Bradycardia 1/233 (0.4%) 2
    Cardiac failure aggravated 1/233 (0.4%) 1
    Cardiomyopathy 1/233 (0.4%) 1
    Congestive heart failure 2/233 (0.9%) 2
    Coronary artery disease 1/233 (0.4%) 1
    Coronary artery stenosis 1/233 (0.4%) 1
    Coronary heart disease 1/233 (0.4%) 1
    Decompensated heart failure 1/233 (0.4%) 1
    Decompensation cardiac 3/233 (1.3%) 3
    Heart failure 2/233 (0.9%) 2
    Heart failure NYHA class III 1/233 (0.4%) 1
    Heart insufficiency 2/233 (0.9%) 2
    Myocardial infarction 2/233 (0.9%) 2
    New onset angina pectoris 1/233 (0.4%) 1
    Non ST segment elevation myocardial infarction 3/233 (1.3%) 3
    Paroxysmal atrial fibrillation 1/233 (0.4%) 1
    Progressive angina 1/233 (0.4%) 1
    Right coronary artery stenosis 1/233 (0.4%) 1
    ST segment elevation myocardial infarction 1/233 (0.4%) 1
    Supraventricular tachycardia 1/233 (0.4%) 1
    Ear and labyrinth disorders
    Supraventricular tachycardia 1/233 (0.4%) 1
    Gastrointestinal disorders
    Abdominal pain 1/233 (0.4%) 2
    Coprostasis 1/233 (0.4%) 1
    Duodenal ulcer hemorrhage 1/233 (0.4%) 1
    Gastrointestinal bleed 1/233 (0.4%) 1
    Melena 1/233 (0.4%) 1
    Nausea 1/233 (0.4%) 1
    Oral hemorrhage 1/233 (0.4%) 1
    Retroperitoneal hematoma 1/233 (0.4%) 1
    Small bowel obstruction 1/233 (0.4%) 1
    Ventral hernia 1/233 (0.4%) 1
    General disorders
    Acute chest pain 1/233 (0.4%) 1
    Chest pain 2/233 (0.9%) 2
    Delayed healing of wound 2/233 (0.9%) 2
    In-stent peripheral artery restenosis 3/233 (1.3%) 3
    Opiate withdrawal symptoms 1/233 (0.4%) 1
    Puncture site bleeding 1/233 (0.4%) 1
    Sudden cardiac death 1/233 (0.4%) 1
    Unknown cause of death 1/233 (0.4%) 1
    Hepatobiliary disorders
    Acute cholecystitis 1/233 (0.4%) 1
    Infections and infestations
    Bacteremia 1/233 (0.4%) 1
    Bacteriuria 1/233 (0.4%) 1
    Cellulitis of toe 1/233 (0.4%) 1
    Clostridial gastroenteritis 1/233 (0.4%) 1
    Erysipelas 1/233 (0.4%) 1
    Gangrene 1/233 (0.4%) 2
    Gangrene peripheral 2/233 (0.9%) 4
    Gangrene toe 5/233 (2.1%) 6
    Infection of amputation stump 1/233 (0.4%) 1
    Osteomyelitis of the foot 4/233 (1.7%) 5
    Phlegmon 1/233 (0.4%) 1
    Pneumonia, organism unspecified 4/233 (1.7%) 5
    Postoperative infection 1/233 (0.4%) 1
    Sepsis 2/233 (0.9%) 2
    Soft tissue infection 1/233 (0.4%) 1
    Spondylodiscitis 1/233 (0.4%) 2
    Staphylococcus aureus bacteremia 1/233 (0.4%) 1
    Urinary tract infection, site not specified 1/233 (0.4%) 1
    Wet gangrene 1/233 (0.4%) 1
    Injury, poisoning and procedural complications
    Abdominal wall wound 1/233 (0.4%) 1
    Chronic subdural hematoma 1/233 (0.4%) 1
    Femoral artery pseudoaneurysm 1/233 (0.4%) 1
    Fracture femur 1/233 (0.4%) 1
    Fracture of neck of femur 1/233 (0.4%) 1
    Overdose NOS 1/233 (0.4%) 1
    Peripheral arterial reocclusion 4/233 (1.7%) 6
    Peripheral artery restenosis 4/233 (1.7%) 4
    Pseudoaneurysm 2/233 (0.9%) 2
    Skin tear 2/233 (0.9%) 2
    Traumatic brain injury 1/233 (0.4%) 1
    Vascular access site bleeding 1/233 (0.4%) 1
    Wound 1/233 (0.4%) 2
    Wound bleeding 1/233 (0.4%) 1
    Metabolism and nutrition disorders
    Gout aggravated 1/233 (0.4%) 1
    Hyperglycemia 3/233 (1.3%) 3
    Hyperkalemia 1/233 (0.4%) 1
    Hypokalemia 1/233 (0.4%) 1
    Hyponatremia 1/233 (0.4%) 4
    Type II diabetes mellitus inadequate control 1/233 (0.4%) 1
    Musculoskeletal and connective tissue disorders
    Coxarthrosis 1/233 (0.4%) 1
    Hyperuricemic arthritis 1/233 (0.4%) 1
    Leg pain 1/233 (0.4%) 1
    Polyarthritis 1/233 (0.4%) 1
    Prepatellar bursitis 1/233 (0.4%) 1
    Soft tissue disorder 1/233 (0.4%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basalioma 1/233 (0.4%) 1
    Diffuse large B-cell lymphoma recurrent 1/233 (0.4%) 1
    Leukemia 1/233 (0.4%) 1
    Liver carcinoma 1/233 (0.4%) 1
    Ovarian granulosa cell tumor 1/233 (0.4%) 1
    Nervous system disorders
    Ataxia 1/233 (0.4%) 1
    Bleeding intracranial 1/233 (0.4%) 1
    Carotid artery stenosis 2/233 (0.9%) 2
    Dizziness 1/233 (0.4%) 1
    Drop attacks 1/233 (0.4%) 1
    Focal epilepsy 1/233 (0.4%) 1
    Stroke 2/233 (0.9%) 2
    Syncopal attack 1/233 (0.4%) 1
    TIA 1/233 (0.4%) 1
    Transient ischemic attack 1/233 (0.4%) 1
    Psychiatric disorders
    Confusion 1/233 (0.4%) 1
    Hyperactive delirium 1/233 (0.4%) 1
    Transient psychosis 1/233 (0.4%) 1
    Renal and urinary disorders
    Acute kidney injury 3/233 (1.3%) 3
    Acute on chronic renal failure 2/233 (0.9%) 2
    Acute renal failure 4/233 (1.7%) 4
    Renal failure 1/233 (0.4%) 1
    Reproductive system and breast disorders
    Metrorrhagia 1/233 (0.4%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/233 (0.4%) 1
    Bilateral pleural effusion 2/233 (0.9%) 2
    Dyspnea 1/233 (0.4%) 1
    Hypoxia 1/233 (0.4%) 1
    Lung edema 1/233 (0.4%) 1
    Shortness of breath 1/233 (0.4%) 1
    Skin and subcutaneous tissue disorders
    Chronic leg ulcer 1/233 (0.4%) 1
    Diabetic foot 1/233 (0.4%) 2
    Digital ulcer 2/233 (0.9%) 2
    Rash 1/233 (0.4%) 1
    Ulcer foot 1/233 (0.4%) 1
    Venous ulceration 1/233 (0.4%) 1
    Surgical and medical procedures
    Medical device battery replacement 1/233 (0.4%) 1
    Vascular disorders
    Abdominal aortic aneurysm 1/233 (0.4%) 1
    Acute limb ischemia 2/233 (0.9%) 2
    Anterior tibial artery perforation 1/233 (0.4%) 1
    Arterial occlusion 1/233 (0.4%) 1
    Arterial stenosis 1/233 (0.4%) 1
    Atherosclerosis of arteries of the extremities 1/233 (0.4%) 1
    Claudication 8/233 (3.4%) 10
    Critical limb ischemia 3/233 (1.3%) 3
    Digital necrosis 1/233 (0.4%) 1
    Dry gangrene foot 1/233 (0.4%) 2
    Dry gangrene toe 1/233 (0.4%) 1
    Extremity necrosis 1/233 (0.4%) 1
    Hematoma 1/233 (0.4%) 1
    Hypertension 1/233 (0.4%) 1
    Hypotension 3/233 (1.3%) 3
    Iliac artery stenosis 1/233 (0.4%) 1
    Internal hemorrhage 1/233 (0.4%) 1
    Ischemic limb pain 1/233 (0.4%) 1
    Peripheral arterial occlusive disease 1/233 (0.4%) 1
    Peripheral arterial occlusive disease Fontaine stage IV 1/233 (0.4%) 1
    Peripheral arterial occlusive disease aggravated 4/233 (1.7%) 5
    Peripheral artery occlusion 1/233 (0.4%) 1
    Peripheral artery thrombosis 1/233 (0.4%) 1
    Peripheral vascular disease 9/233 (3.9%) 10
    Peripheral vascular disease 1/233 (0.4%) 1
    Superficial femoral arterial stenosis 1/233 (0.4%) 1
    Superficial femoral artery occlusion 1/233 (0.4%) 1
    Uncontrolled hypertension 1/233 (0.4%) 1
    Varicose vein 1/233 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Tack Endovascular System (4F)
    Affected / at Risk (%) # Events
    Total 137/233 (58.8%)
    Blood and lymphatic system disorders
    Anemia 4/233 (1.7%) 4
    Microcytic anemia 1/233 (0.4%) 1
    Cardiac disorders
    Acute on chronic heart failure 2/233 (0.9%) 3
    Angina at rest 1/233 (0.4%) 1
    Angina pectoris 1/233 (0.4%) 1
    Aortic valve stenosis 2/233 (0.9%) 2
    Atrial fibrillation 1/233 (0.4%) 1
    Bradycardia 1/233 (0.4%) 2
    Cardiac failure aggravated 1/233 (0.4%) 1
    Congestive heart failure 2/233 (0.9%) 2
    Coronary artery disease 1/233 (0.4%) 1
    Coronary artery stenosis 1/233 (0.4%) 1
    Coronary heart disease 1/233 (0.4%) 1
    Decompensated heart failure 1/233 (0.4%) 1
    Decompensation cardiac 3/233 (1.3%) 3
    Heart failure 2/233 (0.9%) 2
    Heart failure NYHA class III 1/233 (0.4%) 1
    Heart insufficiency 2/233 (0.9%) 2
    Ischaemic heart disease 1/233 (0.4%) 1
    Myocardial infarction 2/233 (0.9%) 2
    New onset angina pectoris 1/233 (0.4%) 1
    Non ST segment elevation myocardial infarction 3/233 (1.3%) 3
    Paroxysmal atrial fibrillation 1/233 (0.4%) 1
    Progressive angina 1/233 (0.4%) 1
    Right coronary artery stenosis 1/233 (0.4%) 1
    ST segment elevation myocardial infarction 1/233 (0.4%) 1
    Supraventricular tachycardia 1/233 (0.4%) 1
    Ear and labyrinth disorders
    Meniere's disease aggravated 1/233 (0.4%) 1
    Gastrointestinal disorders
    Abdominal pain 1/233 (0.4%) 2
    Coprostasis 1/233 (0.4%) 1
    Duodenal ulcer hemorrhage 1/233 (0.4%) 1
    Gastrointestinal bleed 1/233 (0.4%) 1
    Gastrointestinal bleeding 2/233 (0.9%) 2
    Melena 2/233 (0.9%) 2
    Nausea 1/233 (0.4%) 1
    Oral hemorrhage 1/233 (0.4%) 1
    Retroperitoneal hematoma 1/233 (0.4%) 1
    Small bowel obstruction 1/233 (0.4%) 1
    Ventral hernia 1/233 (0.4%) 1
    General disorders
    Acute chest pain 1/233 (0.4%) 1
    Chest pain 2/233 (0.9%) 2
    Delayed healing of wound 3/233 (1.3%) 3
    In-stent peripheral artery restenosis 3/233 (1.3%) 3
    Leg edema 2/233 (0.9%) 2
    Opiate withdrawal symptoms 1/233 (0.4%) 1
    Puncture site bleeding 1/233 (0.4%) 1
    Swelling of limb 1/233 (0.4%) 1
    Hepatobiliary disorders
    Acute cholecystitis 1/233 (0.4%) 1
    Infections and infestations
    Bacteremia 1/233 (0.4%) 1
    Bacteriuria 1/233 (0.4%) 1
    Cellulitis of toe 1/233 (0.4%) 1
    Clostridial gastroenteritis 1/233 (0.4%) 1
    Erysipelas 1/233 (0.4%) 1
    Gangrene 1/233 (0.4%) 2
    Gangrene peripheral 3/233 (1.3%) 5
    Gangrene toe 5/233 (2.1%) 6
    Infection of amputation stump 1/233 (0.4%) 1
    Osteomyelitis of the foot 4/233 (1.7%) 5
    Phlegmon 1/233 (0.4%) 1
    Pneumonia, organism unspecified 4/233 (1.7%) 5
    Postoperative infection 1/233 (0.4%) 1
    Sepsis 2/233 (0.9%) 2
    Soft tissue infection 1/233 (0.4%) 1
    Spondylodiscitis 1/233 (0.4%) 2
    Staphylococcus aureus bacteremia 1/233 (0.4%) 1
    Urinary tract infection, site not specified 1/233 (0.4%) 1
    Vascular access site infection 1/233 (0.4%) 1
    Wet gangrene 1/233 (0.4%) 1
    Injury, poisoning and procedural complications
    Abdominal wall wound 1/233 (0.4%) 1
    Chronic subdural hematoma 1/233 (0.4%) 1
    Femoral artery pseudoaneurysm 1/233 (0.4%) 1
    Fracture femur 1/233 (0.4%) 1
    Fracture of neck of femur 1/233 (0.4%) 1
    Overdose NOS 1/233 (0.4%) 1
    Peripheral arterial reocclusion 8/233 (3.4%) 10
    Peripheral artery restenosis 9/233 (3.9%) 10
    Post procedural bleeding 1/233 (0.4%) 1
    Post procedural complication 4/233 (1.7%) 4
    Post procedural hematoma 3/233 (1.3%) 3
    Pseudoaneurysm 5/233 (2.1%) 5
    Skin tear 1/233 (0.4%) 1
    Traumatic brain injury 1/233 (0.4%) 1
    Vascular access site bleeding 1/233 (0.4%) 1
    Vascular access site hematoma 2/233 (0.9%) 2
    Wound 3/233 (1.3%) 4
    Wound bleeding 1/233 (0.4%) 1
    Metabolism and nutrition disorders
    Gout aggravated 1/233 (0.4%) 1
    Hyperglycemia 3/233 (1.3%) 3
    Hyperkalemia 1/233 (0.4%) 1
    Hypokalemia 1/233 (0.4%) 1
    Hyponatremia 1/233 (0.4%) 4
    Type II diabetes mellitus inadequate control 1/233 (0.4%) 1
    Musculoskeletal and connective tissue disorders
    Coxarthrosis 1/233 (0.4%) 1
    Hyperuricemic arthritis 1/233 (0.4%) 1
    Leg pain 2/233 (0.9%) 2
    Pain of lower extremities 1/233 (0.4%) 1
    Polyarthritis 1/233 (0.4%) 1
    Prepatellar bursitis 1/233 (0.4%) 1
    Soft tissue disorder 1/233 (0.4%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basalioma 1/233 (0.4%) 1
    Diffuse large B-cell lymphoma recurrent 1/233 (0.4%) 1
    Leukemia 1/233 (0.4%) 2
    Liver carcinoma 1/233 (0.4%) 1
    Ovarian granulosa cell tumor 1/233 (0.4%) 1
    Nervous system disorders
    Ataxia 1/233 (0.4%) 1
    Bleeding intracranial 1/233 (0.4%) 1
    Carotid artery stenosis 2/233 (0.9%) 2
    Dizziness 1/233 (0.4%) 1
    Drop attacks 1/233 (0.4%) 1
    Focal epilepsy 1/233 (0.4%) 1
    Stroke 2/233 (0.9%) 2
    Syncopal attack 1/233 (0.4%) 1
    TIA 1/233 (0.4%) 1
    Transient ischemic attack 1/233 (0.4%) 1
    Psychiatric disorders
    Confusion 1/233 (0.4%) 1
    Hyperactive delirium 1/233 (0.4%) 1
    Transient psychosis 1/233 (0.4%) 1
    Renal and urinary disorders
    Acute kidney injury 3/233 (1.3%) 3
    Acute on chronic renal failure 2/233 (0.9%) 2
    Acute renal failure 4/233 (1.7%) 4
    Renal failure 1/233 (0.4%) 1
    Metrorrhagia 1/233 (0.4%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/233 (0.4%) 1
    Bilateral pleural effusion 2/233 (0.9%) 2
    Dyspnea 1/233 (0.4%) 1
    Hypoxia 1/233 (0.4%) 1
    Lung edema 1/233 (0.4%) 1
    Shortness of breath 1/233 (0.4%) 1
    Skin and subcutaneous tissue disorders
    Chronic leg ulcer 1/233 (0.4%) 1
    Diabetic foot 1/233 (0.4%) 2
    Digital ulcer 2/233 (0.9%) 2
    Rash 1/233 (0.4%) 1
    Ulcer foot 1/233 (0.4%) 1
    Venous ulceration 1/233 (0.4%) 1
    Surgical and medical procedures
    Medical device battery replacement 1/233 (0.4%) 1
    Peripheral arterial occlusive disease Fontaine stage IV 1/233 (0.4%) 1
    Vascular disorders
    Abdominal aortic aneurysm 1/233 (0.4%) 1
    Acute limb ischemia 2/233 (0.9%) 2
    Anterior tibial artery perforation 1/233 (0.4%) 1
    Arterial occlusion 1/233 (0.4%) 1
    Arterial spasm 1/233 (0.4%) 1
    Arterial stenosis 2/233 (0.9%) 2
    Arteriovenous fistula 1/233 (0.4%) 1
    Artery dissection 1/233 (0.4%) 1
    Atherosclerosis of arteries of the extremities 1/233 (0.4%) 1
    Claudication 8/233 (3.4%) 10
    Critical limb ischemia 3/233 (1.3%) 3
    Deep vein thrombosis leg 1/233 (0.4%) 1
    Digital necrosis 3/233 (1.3%) 3
    Dry gangrene foot 1/233 (0.4%) 2
    Dry gangrene toe 1/233 (0.4%) 1
    Extremity necrosis 1/233 (0.4%) 1
    Hematoma 1/233 (0.4%) 1
    Hypertension 1/233 (0.4%) 1
    Hypotension 3/233 (1.3%) 3
    Iliac artery stenosis 1/233 (0.4%) 1
    Internal hemorrhage 1/233 (0.4%) 1
    Ischemic limb pain 1/233 (0.4%) 1
    Peripheral arterial occlusive disease 1/233 (0.4%) 1
    Peripheral arterial occlusive disease aggravated 5/233 (2.1%) 6
    Peripheral artery occlusion 1/233 (0.4%) 1
    Peripheral artery thrombosis 1/233 (0.4%) 1
    Peripheral embolism 1/233 (0.4%) 1
    Peripheral vascular disease 9/233 (3.9%) 10
    Popliteal artery occlusion 1/233 (0.4%) 1
    Reperfusion injury 2/233 (0.9%) 2
    Superficial femoral arterial stenosis 1/233 (0.4%) 1
    Superficial femoral artery occlusion 1/233 (0.4%) 1
    Thrombosis 2/233 (0.9%) 2
    Tibial artery occlusion 1/233 (0.4%) 1
    Tibial artery stenosis 1/233 (0.4%) 1
    Tibial artery thrombosis 1/233 (0.4%) 1
    Uncontrolled hypertension 1/233 (0.4%) 1
    Varicose vein 1/233 (0.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    PI acknowledges that Clinical Trial is part of multi-center clinical study. Publication of multi-center data requires prior review and consent of both Sponsor and all participating sites. PI agrees that the first publication of the results of the Clinical Trial shall be made in conjunction with results from other participating sites. Provided, however, that if no multi-center publication is made within one year from database lock, then PI may publish individually.

    Results Point of Contact

    Name/Title Nicolas Aguirre
    Organization Philips Image Guided Therapy
    Phone (612) 297-6655
    Email nicolas.aguirre@philips.com
    Responsible Party:
    Philips Clinical & Medical Affairs Global
    ClinicalTrials.gov Identifier:
    NCT02942966
    Other Study ID Numbers:
    • CA 0137
    First Posted:
    Oct 24, 2016
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Apr 1, 2021