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

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Complete SE Iliac Stent
Complete SE Iliac Stent
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Iliac Artery, Peripheral Vascular Disease (PVD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Michigan Vascular Research Center
  • New York Presbyterian Hospital, Columbia Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Complete SE Iliac Stent

Arm Description

Complete SE Iliac Stent

Outcomes

Primary Outcome Measures

The Number of Participants With Major Adverse Events (MAE)
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

Number of Participants With Acute Success
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)
Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
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
Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
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.

Full Information

First Posted
August 5, 2008
Last Updated
March 7, 2016
Sponsor
Medtronic Endovascular
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00730730
Brief Title
The Complete® Self-Expanding Stent and Stent Delivery System Registry
Official Title
The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
Iliac Artery, Peripheral Vascular Disease (PVD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete SE Iliac Stent
Arm Type
Experimental
Arm Description
Complete SE Iliac Stent
Intervention Type
Device
Intervention Name(s)
Complete SE Iliac Stent
Intervention Description
Iliac stenting
Intervention Type
Device
Intervention Name(s)
Complete SE Iliac Stent
Intervention Description
Self-expanding stent
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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)
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Molnar, MD
Organizational Affiliation
Michigan Vascular Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Gray
Organizational Affiliation
New York Presbyterian Hospital/Columbia Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Vascular Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
New York Presbyterian Hospital, Columbia Campus
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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