search
Back to results

The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study (ACTIVE)

Primary Purpose

Peripheral Vascular Disease

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

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

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 the common iliac artery and/or the external iliac artery;
  • The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% .
  • The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;
  • The lesion length is < 100 mm (10 cm)

Exclusion Criteria:

  • Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified.
  • Tissue loss in the target extremities.
  • The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
  • The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
  • The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement;
  • Other lesions requiring treatment or surgery within 30 days of the procedure (pre or post) with the exception of the non-target lesion(s).
  • Inadequate distal run-off.
  • History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
  • Creatinine > 2.5 mg/dl
  • Platelet count <80,000 cells/mm3 or >700,000 cells/mm3, or a white blood cell (WBC) of <3,000 cells/mm3
  • Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints;
  • Previously enrolled in the Study.

Sites / Locations

  • Michigan Vascular Research Center
  • NY Presbyterian Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assurant Cobalt Iliac Stent

Arm Description

Assurant® Cobalt Iliac Stent System

Outcomes

Primary Outcome Measures

Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).
Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.

Secondary Outcome Measures

Primary Patency Rate at 9 Months
Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.
Device Success
Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
Lesion Success
Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.
Procedure Success
Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)
Clinical Success
Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.
Clinical Success
Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.
Hemodynamic Success
Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.
Hemodynamic Success
Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.
All Cause Mortality
Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.
All Cause Mortality
Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.

Full Information

First Posted
September 15, 2008
Last Updated
March 7, 2016
Sponsor
Medtronic Endovascular
search

1. Study Identification

Unique Protocol Identification Number
NCT00753337
Brief Title
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
Acronym
ACTIVE
Official Title
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
Detailed Description
This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Assurant Cobalt Iliac Stent
Arm Type
Experimental
Arm Description
Assurant® Cobalt Iliac Stent System
Intervention Type
Device
Intervention Name(s)
Assurant® Cobalt Iliac Stent System
Intervention Description
Iliac Stenting
Primary Outcome Measure Information:
Title
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).
Description
Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Primary Patency Rate at 9 Months
Description
Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.
Time Frame
9 months
Title
Device Success
Description
Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
Time Frame
9 months
Title
Lesion Success
Description
Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.
Time Frame
9 months
Title
Procedure Success
Description
Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)
Time Frame
9 months
Title
Clinical Success
Description
Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.
Time Frame
30 days
Title
Clinical Success
Description
Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.
Time Frame
9 months
Title
Hemodynamic Success
Description
Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.
Time Frame
30 days
Title
Hemodynamic Success
Description
Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.
Time Frame
9 months
Title
All Cause Mortality
Description
Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.
Time Frame
30 days
Title
All Cause Mortality
Description
Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.
Time Frame
9 months

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 the common iliac artery and/or the external iliac artery; The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% . The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate; The lesion length is < 100 mm (10 cm) Exclusion Criteria: Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified. Tissue loss in the target extremities. The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis; The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement; Other lesions requiring treatment or surgery within 30 days of the procedure (pre or post) with the exception of the non-target lesion(s). Inadequate distal run-off. History of bleeding diatheses or coagulopathy or will refuse blood transfusions; Creatinine > 2.5 mg/dl Platelet count <80,000 cells/mm3 or >700,000 cells/mm3, or a white blood cell (WBC) of <3,000 cells/mm3 Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints; Previously enrolled in the Study.
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, MD
Organizational Affiliation
NY Presbyterian Hospital
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
NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23391088
Citation
Molnar RG, Gray WA; ACTIVE Trial Investigators. Sustained patency and clinical improvement following treatment of atherosclerotic iliac artery disease using the Assurant cobalt iliac balloon-expandable stent system. J Endovasc Ther. 2013 Feb;20(1):94-103. doi: 10.1583/12-4010.1.
Results Reference
derived

Learn more about this trial

The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study

We'll reach out to this number within 24 hrs