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

This study has been withdrawn prior to enrollment.
ClinicalTrials.gov Identifier:
First Posted: August 17, 2012
Last Update Posted: June 18, 2015
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.
Information provided by (Responsible Party):
Abbott Vascular
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 Intervention Phase
Peripheral Vascular Disease. Device: IDEV SUPERA Stent Device: Percutaneous Transluminal Angioplasty Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Abbott Vascular:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: January 2013
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01667393     History of Changes
Other Study ID Numbers: IDEV POP-01-US/OUS
First Submitted: August 14, 2012
First Posted: August 17, 2012
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