The Study to Compare the Treatment of Angioplasty and Ste... | NCT00289055

Studies
The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.

NCT00289055

Sponsor

Cordis US Corp.

Status

Terminated

Last Update Posted

Feb 24, 2009Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Arterial Occlusive Diseases

Interventions

stent
angioplasty

Countries

Netherlands

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of enrollment

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Feb 7, 2006

First Submission Date that Met QC Criteria

Feb 8, 2006

First Posted Date

Feb 9, 2006Estimated

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

Feb 20, 2009

Last Update Posted Date

Feb 24, 2009Estimated

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

The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

Detailed Description

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted at 8 investigational sites in The Netherlands.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cordis SMART™ Nitinol Stent	Device: stent
2	Active Comparator	balloon angioplasty	Device: angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stent	Device	Cordis SMART™ Nitinol Stent	1
angioplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary patency.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.		at deployment
Procedural success defined as successful recanalization, without the occurrence of a SAE.		up to the moment haemostasis has been achieved

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.

Exclusion Criteria:

Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
Gangrene in index limb (Rutherford category 6).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jim Reekers, MD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AMC		Amsterdam		1105 AZ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D001157	Arterial Occlusive Diseases
C564658	Peripheral Arterial Occlusive Disease 1

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
D015607	Stents
D017130	Angioplasty

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D002404	Catheterization
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided