The Complete® Self-Expanding Stent and Stent Delivery System Registry

• Sponsor: Medtronic Endovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00730730
• Collaborator: Medtronic (Industry)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 57
• Patients Per Site: 25
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Disease	Device: Complete SE Iliac Stent; Device: Complete SE Iliac Stent	N/A

Detailed Description

The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Complete SE Iliac Stent Complete SE Iliac Stent	Device: Complete SE Iliac Stent; Iliac stenting; Device: Complete SE Iliac Stent; Self-expanding stent

Outcome Measures

Primary Outcome Measures

1. The Number of Participants With Major Adverse Events (MAE) [30 days]

   Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry

Secondary Outcome Measures

1. Number of Participants With Acute Success [from after stent placement to prior to hospital discharge (up to 3 days)]

   angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)

2. Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success. [From baseline up to 30-days]

   Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up- Category 0: Asymptomatic, no hemodynamically significant occlusive disease; Category 1: Mild claudication; Category 2: Moderate claudication; Category 3: Severe claudication; Category 4: Ischemic rest pain; Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia; Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable

3. Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success. [From baseline up to 30-days]

   Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI. An ABI ≥ 0.90 is considered normal.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• The lesion(s) is either de-novo or restenotic in nature, located in either the common iliac artery or the external iliac artery and is >50% stenosed

• Target vessel reference diameter ≥ 4.5 mm and ≤ 9.5 and can accommodate stent diameters of 6.0 - 10.0mm

• Subject is either asymptomatic with a lesion stenosis ≥70% or symptomatic with a lesion stenosis ≥50% with an Ankle Brachial Index (ABI) < 0.90 or Toe Brachial Index (TBI) <0.80 or an abnormal Pulse Volume Recording (PVR);

• Total lesion length is < 110 mm;

Exclusion Criteria:

• Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ;

• Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;

• Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;

• Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion;

• Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement;

• Inadequate distal run-off;

• Planned interventional procedure or vascular surgery to target vessel within 30 days pre- or post-index iliac procedure;

• History of bleeding diatheses or coagulopathy or will refuse blood transfusions;

• Platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or White Blood Count (WBC) <3,000 cells/mm3;

• Creatinine >2.0 mg/dl;

• Participation in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial or the subject has previously been enrolled in this Registry;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michigan Vascular Research Center	Flint	Michigan	United States	48507
2	New York Presbyterian Hospital, Columbia Campus	New York	New York	United States	10032

Sponsors and Collaborators

• Medtronic Endovascular
• Medtronic

Investigators

• Principal Investigator: Robert G Molnar, MD, Michigan Vascular Research Center
• Principal Investigator: William Gray, New York Presbyterian Hospital/Columbia Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT00730730
• Other Study ID Numbers: IP084; IDE G070114
• First Posted: Aug 8, 2008
• Last Update Posted: Apr 4, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Medtronic Endovascular: Iliac Artery, Peripheral Vascular Disease (PVD)
• Additional relevant MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease

Study Results

Participant Flow

Arm/Group Title	Complete SE Iliac Stent
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Iliac Stenting
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (12)
Sex: Female, Male (Count of Participants)
Female	22 44%
Male	28 56%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	The Number of Participants With Major Adverse Events (MAE)
Description	Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat population (ITT)

Arm/Group Title	Complete SE Iliac Stent
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Measure Participants	50
Number [participants]	0 0%

2. Secondary Outcome

Title	Number of Participants With Acute Success
Description	angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)
Time Frame	from after stent placement to prior to hospital discharge (up to 3 days)

Outcome Measure Data

Analysis Population Description

Intent to Treat population(ITT); missing angiographic data for one patient

Arm/Group Title	Complete SE Iliac Stent
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Measure Participants	49
Number [participants]	44 88%

3. Secondary Outcome

Title	Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
Description	Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up- Category 0: Asymptomatic, no hemodynamically significant occlusive disease; Category 1: Mild claudication; Category 2: Moderate claudication; Category 3: Severe claudication; Category 4: Ischemic rest pain; Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia; Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable
Time Frame	From baseline up to 30-days

Outcome Measure Data

Analysis Population Description

Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs

Arm/Group Title	Complete SE Iliac Stent
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Measure Participants	50
Measure limbs	54
Number [limbs]	46

4. Secondary Outcome

Title	Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
Description	Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI. An ABI ≥ 0.90 is considered normal.
Time Frame	From baseline up to 30-days

Outcome Measure Data

Analysis Population Description

Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb

Arm/Group Title	Complete SE Iliac Stent
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Measure Participants	50
Measure limbs	55
Number [limbs]	55

Adverse Events

Time Frame	30 days
Arm/Group Title	Iliac Stenting
Arm/Group Description	Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
All Cause Mortality
	Iliac Stenting
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Iliac Stenting
	Affected / at Risk (%)	# Events
Total	5/50 (10%)
Cardiac disorders
Congestive Heart Failure	1/50 (2%)	1
Coronary Artery Disease	1/50 (2%)	1
NSTEMI - Acute	1/50 (2%)	1
Ventricular Tachycardia	1/50 (2%)	1
Gastrointestinal disorders
Retroperitoneal Bleed	1/50 (2%)	1
Hepatobiliary disorders
Shock Liver	1/50 (2%)	1
Injury, poisoning and procedural complications
Pseudoaneurysm Left Femoral Artery	1/50 (2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer	1/50 (2%)	1
Renal and urinary disorders
Acute Renal Failure	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	1/50 (2%)	1
Vascular disorders
Dissection - Target Vessel	1/50 (2%)	1
Right Lower Extremity Gangrene	1/50 (2%)	1
Right Toe Gangrene	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Iliac Stenting
	Affected / at Risk (%)	# Events
Total	4/50 (8%)
Musculoskeletal and connective tissue disorders
Back Pain	4/50 (8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Investigator/Institution agree to submit to Sponsor copies of any proposed publication/public presentation ("Proposed Publication") at least sixty (60) calendar days in advance of dissemination. Sponsor will review/comment within thirty (30) calendar days after receipt thereof. If Sponsor objects to dissemination of any part of the Proposed Publication, Investigator, and Institution shall refrain from disseminating or presenting such Proposed Publication until Sponsor is satisfied.