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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00753337
First received: September 15, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Peripheral Vascular Disease
Device: Assurant® Cobalt Iliac Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

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). [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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 Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.

  • Lesion Success [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method.

  • Procedure Success [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 123
Study Start Date: October 2008
Study Completion Date: September 2013
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assurant Cobalt Iliac Stent
Assurant® Cobalt Iliac Stent System
Device: Assurant® Cobalt Iliac Stent System
Iliac Stenting

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753337

Locations
United States, Michigan
Michigan Vascular Research Center
Flint, Michigan, United States, 48507
United States, New York
NY Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Robert G Molnar, MD Michigan Vascular Research Center
Principal Investigator: William Gray, MD NY Presbyterian Hospital
  More Information

No publications provided by Medtronic Endovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00753337     History of Changes
Other Study ID Numbers: IP085
Study First Received: September 15, 2008
Results First Received: February 10, 2012
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014