The Study to Treat Superficial Femoral Artery Occlusions.

Arterial Occlusive Diseases Clinical Trial

— SUPER UK  

Official title:

A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232843
• Other study ID #: EE04-01UK
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: June 2, 2009
• Start date: March 2005
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

Description:

This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only.

It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only.

150 patients with de novo or restenotic native SFA occlusions (5-22 cm) with reference vessel of >= 4.0 to <= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only.

All patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• One superficial femoral artery de novo or restenotic lesion (> 70% stenosis or occlusions), with a lesion length > 5 to < 22 cm.

• Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions

Exclusion Criteria:

• Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion.

• Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Device:
• stent
Cordis SMART™ nitinol self-expanding stent.
• angioplasty
balloon angioplasty

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	University Hospital of North Staffordshire	Newcastle under Lyme

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary restenosis as demonstrated by Duplex Ultrasound.		1 year	Yes
Secondary	Device success.		at time of deployment	No
Secondary	Procedural success: defined as successful recanalization, without the occurrence of a SAE event.		up to the moment the catheter sheath introducer has been removed	Yes
Secondary	Ankle Brachial Index		at discharge and 12 months	Yes
Secondary	Restenosis measured by Duplex Ultrasound		at discharge and 12 months	Yes