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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00232843
Other study ID # EE04-01UK
Secondary ID
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


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
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