Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System (PARADIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667393
Recruitment Status : Withdrawn
First Posted : August 17, 2012
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
Abbott Vascular

Brief Summary:
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease. Device: IDEV SUPERA Stent Device: Percutaneous Transluminal Angioplasty Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System
Study Start Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: IDEV SUPERA Stent
Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.
Device: IDEV SUPERA Stent
Active Comparator: Percutaneous Transluminal Angioplasty
The target lesion will be treated by PTA alone.
Device: Percutaneous Transluminal Angioplasty

Primary Outcome Measures :
  1. Primary patency [ Time Frame: 12 months ]
    Primary efficacy will be target lesion primary patency at 12 months.

Secondary Outcome Measures :
  1. MAE-free survival rate. [ Time Frame: 12 months ]
    Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

Exclusion Criteria:

  • Inteervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

Responsible Party: Abbott Vascular Identifier: NCT01667393     History of Changes
Other Study ID Numbers: IDEV POP-01-US/OUS
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases