The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medtronic Vascular.
Recruitment status was Active, not recruiting
Information provided by:
First received: September 15, 2008
Last updated: June 22, 2011
Last verified: June 2011
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).
Peripheral Vascular Disease
Device: Assurant® Cobalt Iliac Stent System
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Major adverse events (MAE), measured as device and/or procedure related death, target limb loss and/or clinically driven target lesion or target vessel revascularization (TLR/TVR). [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Primary patency rate of the target vessel(s) at 9 months as determined by duplex ultrasound scan, measured by duplex ultrasound scan [ Time Frame: 30 days, 9 months ] [ Designated as safety issue: Yes ]
- Acute success (device, lesion, and procedure) [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
- Clinical success [ Time Frame: 30 days, 9 months ] [ Designated as safety issue: No ]
- Hemodynamic success [ Time Frame: 30 days, 9 months ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 30 days, 9 months, 3 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||February 2011 (Final data collection date for primary outcome measure)
treatment with iliac stenting
Device: Assurant® Cobalt Iliac Stent System
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753337
|Michigan Vascular Research Center
|Flint, Michigan, United States |
|NY Presbyterian Hospital
|New York, New York, United States |
||Robert G Molnar, MD
||Michigan Vascular Research Center
||William Gray, MD
||NY Presbyterian Hospital
No publications provided by Medtronic Vascular
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Beaux Alexander, Director, Clinical Research, Medtronic CardioVascular
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 15, 2008
||June 22, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Physiological Effects of Drugs