Popliteal Artery of Treatment With Balloon Angioplasty vs... | NCT01667393

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

NCT01667393

Sponsor

Abbott Medical Devices

Status

Withdrawn

Last Update Posted

Apr 17, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Peripheral Vascular Disease

Interventions

IDEV SUPERA Stent
Percutaneous Transluminal Angioplasty

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2013

Completion Date

Jan 2013

First Submitted Date

Aug 14, 2012

First Submission Date that Met QC Criteria

Aug 15, 2012

First Posted Date

Aug 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2019

Last Update Posted Date

Apr 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IDEV SUPERA Stent	Device		IDEV SUPERA Stent
Percutaneous Transluminal Angioplasty

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017130	Angioplasty

Ancestor Terms

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided