Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System (PARADIGM)
This study is not yet open for participant recruitment.
Verified August 2012 by IDev Technologies, Inc.
Sponsor:
IDev Technologies, Inc.
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
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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
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 May 22, 2013