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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01667393

Acronym

PARADIGM

Enrollment

Registered

2012-08-17

Start date

2013-01-31

Completion date

2013-01-31

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

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.

Interventions

DEVICEIDEV SUPERA Stent

DEVICEPercutaneous Transluminal Angioplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary patency	12 months	Primary efficacy will be target lesion primary patency at 12 months.

Secondary

Measure	Time frame	Description
MAE-free survival rate.	12 months	Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026