Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

IDEV SUPERA Stent

+ Percutaneous Transluminal Angioplasty

Device
Who is being recruted

Cardiovascular Diseases

+ Vascular Diseases

+ Peripheral Vascular Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorAbbott Medical Devices
Last updated: April 17, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01667393
Principal SponsorAbbott Medical Devices
Last updated: April 17, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesVascular DiseasesPeripheral Vascular Diseases

Criteria

1 inclusion criteria required to participate
Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion
1 exclusion criteria prevent from participating
Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.

Group II

Active Comparator
The target lesion will be treated by PTA alone.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers