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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by IDev Technologies, Inc.
Sponsor:
Information provided by (Responsible Party):
IDev Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01667393
First received: August 14, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 IDev Technologies, Inc.:

Primary Outcome Measures:
  • Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Primary efficacy will be target lesion primary patency at 12 months.


Secondary Outcome Measures:
  • MAE-free survival rate. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.


Estimated Enrollment: 318
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667393

Contacts
Contact: Carol C Base, BSN, MS 281-525-2000 cbase@idevmd.com

Sponsors and Collaborators
IDev Technologies, Inc.
  More Information

No publications provided

Responsible Party: IDev Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01667393     History of Changes
Other Study ID Numbers: IDEV POP-01-US/OUS
Study First Received: August 14, 2012
Last Updated: August 15, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014