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NCT Number: NCT00753337

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

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).

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Vascular Research Center, Flint, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assurant® Cobalt Iliac Stent System

Device

Iliac Stenting

Primary outcomes

  1. 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

    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 outcomes

  1. Primary Patency Rate at 9 Months

    Time frame: 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.

  2. Device Success

    Time frame: 9 months

    Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.

  3. Lesion Success

    Time frame: 9 months

    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.

  4. Procedure Success

    Time frame: 9 months

    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)

  5. Clinical Success

    Time frame: 30 days

    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.

  6. Clinical Success

    Time frame: 9 months

    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.

  7. Hemodynamic Success

    Time frame: 30 days

    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.

  8. Hemodynamic Success

    Time frame: 9 months

    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.

  9. All Cause Mortality

    Time frame: 30 days

    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.

  10. All Cause Mortality

    Time frame: 9 months

    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.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study 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

Acronym: ACTIVE

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Sep 16, 2008
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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