OPTIMIZE BTK: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

• Sponsor: Cardiovascular Systems Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02561299
• Collaborator: (none)
• Enrollment: 66
• Locations: 7
• Arms: 2
• Actual Duration (Months): 46
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Condition or Disease	Intervention/Treatment	Phase
PAD; Vascular Calcification	Device: Peripheral Orbital Atherectomy System; Device: 014 Drug Coated Balloon	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Jul 2, 2019
• Actual Study Completion Date: Jul 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OA with adjunctive DCB angioplasty Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty	Device: Peripheral Orbital Atherectomy System; Orbital Atherectomy; Device: 014 Drug Coated Balloon; Drug Coated Balloon
Active Comparator: DCB angioplasty 014 Drug Coated Balloon angioplasty	Device: 014 Drug Coated Balloon; Drug Coated Balloon

Outcome Measures

Primary Outcome Measures

1. Device Success [During the procedure]

   Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used.

2. Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure [6 months and 12 months post-procedure]

   Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as <50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory.

3. Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure [6 months and 12 months post-procedure]

   A Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months.

4. Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure [6 months and 12 months post-procedure]

   A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months.

5. Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure [6 months and 12 months post-procedure]

   A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure.

6. Change in Rutherford Category at 6 Months and 12 Months Post-Procedure [Baseline, 6 months and 12 months post-procedure]

   Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss. The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subject's age ≥ 18 years

• Rutherford Clinical Category 3 - 5

• Lesions [except in-stent restenosis (ISR)] of the distal popliteal (POP segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (DS) by angiography

• Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- [Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care]

• Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length

• Target lesion length up to 20 cm

Exclusion Criteria:

• Subject or subject's legal representative is not willing to sign an Ethics Committee approved informed consent form or comply with the study protocol requirements

• Contraindicated by either device, per Instructions For Use

• Presence of inflow lesion (≥ 50 % DS) or inflow not successfully treated (≥ 50% DS and/or unresolved significant angiographic complication)

• Compromised outflow distal to the target lesion (≥ 70 % DS) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space

• Subject has more than 2 target vessels requiring treatment

• The guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen

• Presence of significant (≥ 70 % DS) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % DS and/or significant angiographic complication)

• Subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb

• Creatinine > 2.5 mg/dL, unless on dialysis

• Subject has any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study

• Subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures

• Subject is pregnant or planning to become pregnant within the study period

• Subject has an unresolved severe systemic infection

• Subject has an anticipated life span of less than one year

• Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds

• Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy

• Pre-dilatation of the target lesion prior to randomization and OA treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria
2	Vascular Clinic - Hanusch Hospital	Wien		Austria
3	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen		Germany
4	Fürst-Strium-Klinik Bruchsal	Bruchsal		Germany
5	SRH Klinikum Karlsbad- Langensteinbach GmbH	Langensteinbach		Germany
6	Universität Leipzig	Leipzig		Germany
7	Romed Klinikum Rosenheim	Rosenheim		Germany

Sponsors and Collaborators

• Cardiovascular Systems Inc

Investigators

• Principal Investigator: Professor Marianne Brodmann, Dr., Medical University of Graz, Austria
• Principal Investigator: Professor Gunnar Tepe, Dr., Klinikum Rosenheim Germany
• Principal Investigator: Professor Thomas Zeller, Dr., Herz-Zentrum Bad Krozingen Germany

Study Documents (Full-Text)

• Study Protocol - May 20, 2016
• Statistical Analysis Plan - Mar 15, 2019

More Information

Publications

None provided.

• Responsible Party: Cardiovascular Systems Inc
• ClinicalTrials.gov Identifier: NCT02561299
• Other Study ID Numbers: CLN-0007-P
• First Posted: Sep 28, 2015
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Cardiovascular Systems Inc: Drug-coated Balloons; Calcified Lesions; Orbital Atherectomy; Below the Knee; Paclitaxel; Lutonix 014 Drug-coated Balloon
• Additional relevant MeSH terms: Vascular Calcification

Study Results

Participant Flow

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Period Title: Overall Study
STARTED	32	34
COMPLETED	27	28
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty	Total
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon	Total of all reporting groups
Overall Participants	32	34	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.4 (8.5)	76.5 (7.1)	75.0 (7.9)
Sex: Female, Male (Count of Participants)
Female	6 18.8%	9 26.5%	15 22.7%
Male	26 81.3%	25 73.5%	51 77.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Rutherford Clinical Category (Count of Participants)
Severe Claudication (3)	10 31.3%	8 23.5%	18 27.3%
Ischemic Rest Pain (4)	2 6.3%	4 11.8%	6 9.1%
Minor Tissue Loss (5)	20 62.5%	22 64.7%	42 63.6%

Outcome Measures

1. Primary Outcome

Title	Device Success
Description	Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used.
Time Frame	During the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Measure Participants	32	34
Measure Drug Coated Balloons	45	48
Count of Units [Drug Coated Balloons]	42	39

2. Primary Outcome

Title	Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure
Description	Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as <50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory.
Time Frame	6 months and 12 months post-procedure

Outcome Measure Data

Analysis Population Description

Lesions with available data for patency assessment by the DUS Core Lab

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Measure Participants	32	34
Measure Lesions	35	37
Patency at 6 months	15	5
Patency at 12 months	15	6

3. Primary Outcome

Title	Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure
Description	A Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months.
Time Frame	6 months and 12 months post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Measure Participants	32	34
Freedom from CD-TLR at 6 months	96.8	94.1
Freedom from CD-TLR at 12 months	86.4	91.0

4. Primary Outcome

Title	Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure
Description	A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months.
Time Frame	6 months and 12 months post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Measure Participants	32	34
Freedom from major amputation at 6 months	100.0	100.0
Freedom from major amputation at 12 months	96.6	100.0

5. Primary Outcome

Title	Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure
Description	A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure.
Time Frame	6 months and 12 months post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Measure Participants	32	34
Freedom from MAE at 6 months	90.6	91.2
Freedom from MAE at 12 months	77.7	85.3

6. Primary Outcome

Title	Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Description	Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss. The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure.
Time Frame	Baseline, 6 months and 12 months post-procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed at 6 and 12 months differs from the overall number due to missing data.

Arm/Group Title	OA With Adjunctive DCB Angioplasty	DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon	014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
Measure Participants	32	34
Rutherford Category 0	0 0%	0 0%
Rutherford Category 1	0 0%	0 0%
Rutherford Category 2	0 0%	0 0%
Rutherford Category 3	10 31.3%	8 23.5%
Rutherford Category 4	2 6.3%	4 11.8%
Rutherford Category 5	20 62.5%	22 64.7%
Rutherford Category 6	0 0%	0 0%
Rutherford Category 0	6 18.8%	7 20.6%
Rutherford Category 1	5 15.6%	1 2.9%
Rutherford Category 2	2 6.3%	0 0%
Rutherford Category 3	1 3.1%	1 2.9%
Rutherford Category 4	0 0%	0 0%
Rutherford Category 5	8 25%	8 23.5%
Rutherford Category 6	0 0%	0 0%
Rutherford Category 0	10 31.3%	8 23.5%
Rutherford Category 1	3 9.4%	3 8.8%
Rutherford Category 2	2 6.3%	1 2.9%
Rutherford Category 3	4 12.5%	1 2.9%
Rutherford Category 4	0 0%	0 0%
Rutherford Category 5	5 15.6%	5 14.7%
Rutherford Category 6	0 0%	0 0%

Adverse Events

Time Frame	Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
Adverse Event Reporting Description	All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
Arm/Group Title	OA With Adjunctive DCB Angioplasty		DCB Angioplasty
Arm/Group Description	Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty Peripheral Orbital Atherectomy System: Orbital Atherectomy 014 Drug Coated Balloon: Drug Coated Balloon		014 Drug Coated Balloon angioplasty 014 Drug Coated Balloon: Drug Coated Balloon
All Cause Mortality
	OA With Adjunctive DCB Angioplasty		DCB Angioplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/32 (6.3%)		4/34 (11.8%)
Serious Adverse Events
	OA With Adjunctive DCB Angioplasty		DCB Angioplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/32 (90.6%)		22/34 (64.7%)
Cardiac disorders
Angina Pectoris (Ischemic Chest Pain)	0/32 (0%)	0	1/34 (2.9%)	1
Arrhythmias	0/32 (0%)	0	2/34 (5.9%)	2
Cardiac/Cardiopulmonary Arrest	0/32 (0%)	0	1/34 (2.9%)	1
Cardiac Dysfunction-Acute Heart Failure	1/32 (3.1%)	1	1/34 (2.9%)	1
Cardiac Dysfunction-Chronic Heart Failure or Aggravated	2/32 (6.3%)	3	5/34 (14.7%)	5
Cardiac Valve Disorders	1/32 (3.1%)	1	1/34 (2.9%)	1
Coronary Artery Stenosis	2/32 (6.3%)	2	0/34 (0%)	0
Myocardial Infarction	4/32 (12.5%)	4	0/34 (0%)	0
Cardiac-Other	1/32 (3.1%)	1	0/34 (0%)	0
Gastrointestinal disorders
Gastrointestinal Infection/Inflammation	1/32 (3.1%)	1	1/34 (2.9%)	1
Hemorrhoids	1/32 (3.1%)	1	0/34 (0%)	0
Digestive Disorders-Other	1/32 (3.1%)	1	2/34 (5.9%)	2
General disorders
Blood and Lymphatic System Disorder-Anemia	1/32 (3.1%)	1	1/34 (2.9%)	1
Blood and Lymphatic System Disorders-Other	0/32 (0%)	0	1/34 (2.9%)	1
Cancer	1/32 (3.1%)	1	2/34 (5.9%)	3
Chest Pain, Non-Cardiac	0/32 (0%)	0	1/34 (2.9%)	1
Chest Pain, Unspecified	1/32 (3.1%)	1	0/34 (0%)	0
Endocrine/Metabolic Disorders	1/32 (3.1%)	2	2/34 (5.9%)	2
Infection-Other-Localized	1/32 (3.1%)	1	1/34 (2.9%)	1
Infection-Systemic	2/32 (6.3%)	3	1/34 (2.9%)	1
Injury/Trauma	3/32 (9.4%)	3	4/34 (11.8%)	4
Multi-Organ Failure	0/32 (0%)	0	2/34 (5.9%)	2
Pain-Other	0/32 (0%)	0	1/34 (2.9%)	1
Perhipheral Edema	0/32 (0%)	0	1/34 (2.9%)	1
Shock	1/32 (3.1%)	1	0/34 (0%)	0
Sleep Disorders	0/32 (0%)	0	1/34 (2.9%)	1
Adverse Event-Other	0/32 (0%)	0	1/34 (2.9%)	2
Hepatobiliary disorders
Hepatic/Biliary System Disorders (e.g liver, bile duct)	0/32 (0%)	0	1/34 (2.9%)	1
Injury, poisoning and procedural complications
Peripheral Artery Aneurysm	0/32 (0%)	0	1/34 (2.9%)	1
Peripheral Artery Psedoaneurysm	1/32 (3.1%)	1	0/34 (0%)	0
Peripheral Artery Thrombus/Thrombosis	0/32 (0%)	0	1/34 (2.9%)	1
Nervous system disorders
Intracranial Hemorrhage	1/32 (3.1%)	1	0/34 (0%)	0
Stroke	4/32 (12.5%)	4	0/34 (0%)	0
Syncope/Loss of Consciousness	2/32 (6.3%)	2	1/34 (2.9%)	1
Psychiatric disorders
Chronic Mental Illness (e.g. anxiety, depression)	1/32 (3.1%)	1	0/34 (0%)	0
Renal and urinary disorders
Acute Renal Failure	1/32 (3.1%)	2	1/34 (2.9%)	1
Chronic Renal Failure or Worsened	1/32 (3.1%)	1	0/34 (0%)	0
Urinary Tract Infection (UTI)	3/32 (9.4%)	3	1/34 (2.9%)	2
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)	0/32 (0%)	0	1/34 (2.9%)	4
Pleural Effusion	0/32 (0%)	0	1/34 (2.9%)	1
Pneumonia	2/32 (6.3%)	3	2/34 (5.9%)	3
Respiratory Failure	1/32 (3.1%)	1	0/34 (0%)	0
Respiratory Tract Infection	0/32 (0%)	0	1/34 (2.9%)	1
Respiratory/Thoracic Disorders-Other	0/32 (0%)	0	2/34 (5.9%)	3
Vascular disorders
New/Worsening Infection	10/32 (31.3%)	16	5/34 (14.7%)	10
New/Worsening Pain	6/32 (18.8%)	7	2/34 (5.9%)	2
New/Worsening Wound	8/32 (25%)	17	8/34 (23.5%)	13
Peripheral Artery Restenosis	4/32 (12.5%)	6	6/34 (17.6%)	9
Peripheral Artery Stenosis	5/32 (15.6%)	6	8/34 (23.5%)	9
Peripheral Thrombus/Thrombosis	1/32 (3.1%)	1	0/34 (0%)	0
Bleeding/Hemorrhage,Access Site	1/32 (3.1%)	1	0/34 (0%)	0
Bleeding/Hemorrhage, Non Access Site	2/32 (6.3%)	2	0/34 (0%)	0
Carotid Artery Disease	0/32 (0%)	0	1/34 (2.9%)	1
Hypertension	1/32 (3.1%)	2	1/34 (2.9%)	2
Other (Not Including Serious) Adverse Events
	OA With Adjunctive DCB Angioplasty		DCB Angioplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/32 (12.5%)		2/34 (5.9%)
General disorders
Blood and Lymphatic System Disorder-Anemia	0/32 (0%)	0	2/34 (5.9%)	2
Injury, poisoning and procedural complications
Peripheral Artery Perforation	2/32 (6.3%)	2	0/34 (0%)	0
Peripheral Artery Thrombus/Thrombosis	2/32 (6.3%)	2	0/34 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.