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

Peripheral Vascular Disease Clinical Trial

— PARADIGM  

Official title:

Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01667393
• Other study ID #: IDEV POP-01-US/OUS
• Status: Withdrawn
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2013

Study information

• Verified date: April 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• IDEV SUPERA Stent

• Percutaneous Transluminal Angioplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Primary efficacy will be target lesion primary patency at 12 months.	12 months
Secondary	MAE-free survival rate.	Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.	12 months