NCT01667393

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

Same day

First QC Date

August 14, 2012

Last Update Submit

April 15, 2019

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Primary patency

    Primary efficacy will be target lesion primary patency at 12 months.

    12 months

Secondary Outcomes (1)

  • MAE-free survival rate.

    12 months

Study Arms (2)

IDEV SUPERA Stent

EXPERIMENTAL

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

Device: IDEV SUPERA Stent

Percutaneous Transluminal Angioplasty

ACTIVE COMPARATOR

The target lesion will be treated by PTA alone.

Device: Percutaneous Transluminal Angioplasty

Interventions

IDEV SUPERA StentDEVICE
IDEV SUPERA Stent
Percutaneous Transluminal AngioplastyDEVICE
Percutaneous Transluminal Angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

You may not qualify if:

  • Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 17, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 17, 2019

Record last verified: 2019-04