Back to resultsPopliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System (PARADIGM)
Primary Purpose
Peripheral Vascular Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IDEV SUPERA Stent
Percutaneous Transluminal Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease
Eligibility 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:
- Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IDEV SUPERA Stent
Percutaneous Transluminal Angioplasty
Arm Description
Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.
The target lesion will be treated by PTA alone.
Outcomes
Primary Outcome Measures
Primary patency
Primary efficacy will be target lesion primary patency at 12 months.
Secondary Outcome Measures
MAE-free survival rate.
Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01667393
Brief Title
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System
Acronym
PARADIGM
Official Title
Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2013 (undefined)
Study Completion Date
January 2013 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDEV SUPERA Stent
Arm Type
Experimental
Arm Description
Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.
Arm Title
Percutaneous Transluminal Angioplasty
Arm Type
Active Comparator
Arm Description
The target lesion will be treated by PTA alone.
Intervention Type
Device
Intervention Name(s)
IDEV SUPERA Stent
Intervention Type
Device
Intervention Name(s)
Percutaneous Transluminal Angioplasty
Primary Outcome Measure Information:
Title
Primary patency
Description
Primary efficacy will be target lesion primary patency at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MAE-free survival rate.
Description
Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.
12. IPD Sharing Statement
Learn more about this trial
Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System
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