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

NCT00753337 | Completed Results DMC

• 1 other identifier: IP085
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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).

Conditions

Peripheral Vascular Disease

Outcome Measures

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).

  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 Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device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

Secondary Outcomes (10)

• Primary Patency Rate at 9 Months

  9 months

• Device Success

  9 months

• Lesion Success

  9 months

• Procedure Success

  9 months

• Clinical Success

  30 days

Study Arms (1)

Assurant Cobalt Iliac Stent

EXPERIMENTAL

Assurant® Cobalt Iliac Stent System

Device: Assurant® Cobalt Iliac Stent System

Interventions

Assurant® Cobalt Iliac Stent System DEVICE

Iliac Stenting

Assurant Cobalt Iliac Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (2)

Michigan Vascular Research Center

Flint, Michigan, 48507, United States

Location

NY Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 23391088 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Arslan Malik - Senior Clinical Research Manager
• Organization: Medtronic Aortic and Peripheral Vascular

arslan.malik@medtronic.com

(707) 541-3256

Study Officials

• Robert G Molnar, MD

  Michigan Vascular Research Center

  PRINCIPAL INVESTIGATOR

• William Gray, MD

  NY Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2013
• Last Updated: April 4, 2016
• Results First Posted: December 30, 2013

Record last verified: 2016-02

Locations

US (2)