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

Peripheral Vascular Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753337
• Other study ID #: IP085
• Status: Completed
• Phase: N/A
• First received: September 15, 2008
• Last updated: January 28, 2016
• Start date: October 2008
• Est. completion date: September 2013

Study information

• Verified date: January 2016
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Assurant® Cobalt Iliac Stent System
Iliac Stenting

Locations

Country	Name	City	State
United States	Michigan Vascular Research Center	Flint	Michigan
United States	NY Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months	Yes
Secondary	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.	9 months	No
Secondary	Device Success	Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.	9 months	No
Secondary	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.	9 months	No
Secondary	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)	9 months	No
Secondary	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.	30 days	No
Secondary	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.	9 months	No
Secondary	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.	30 days	No
Secondary	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.	9 months	No
Secondary	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.	30 days	No
Secondary	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.	9 months	No