Clinical trial NCT00232843: The Study to Treat Superficial Femoral Artery Occlusions.
Official title: A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Occlusive Diseases
Keywords: Peripheral Artery Occlusive Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Binary restenosis as demonstrated by Duplex Ultrasound.
timeFrame: 1 year
Secondary outcomes:
measure: Device success.
timeFrame: at time of deployment
measure: Procedural success: defined as successful recanalization, without the occurrence of a SAE event.
timeFrame: up to the moment the catheter sheath introducer has been removed
measure: Ankle Brachial Index
timeFrame: at discharge and 12 months
measure: Restenosis measured by Duplex Ultrasound
timeFrame: at discharge and 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle under Lyme
country: United Kingdom
facility: University Hospital of North Staffordshire
Study officials:
affiliation: Manchester Royal Infirmary
name: Nick Chalmers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Staffordshire
name: Mark Cowling, MD
role: PRINCIPAL_INVESTIGATOR
References: