A Phase 4 interventional study of stent and angioplasty in Arterial Occlusive Diseases, sponsored by Cordis Corporation. Terminated at 1 site in Netherlands. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2009-02-24.
Sponsored by Cordis Corporation · Phase 4, Interventional, and Treatment
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.
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.
296 studies on the registry are indexed under Arterial Occlusive Diseases; 46 are open to participants now.
This study's enrollment of 10 is below the median of 121 across 200 interventional studies indexed under Arterial Occlusive Diseases.
Browse Arterial Occlusive Diseases studies →Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cordis SMART™ Nitinol Stent
Device: stent
balloon angioplasty
Device: angioplasty
Cordis SMART™ Nitinol Stent
balloon angioplasty
Primary patency.
Time frame: 12 months
Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.
Time frame: at deployment
Procedural success defined as successful recanalization, without the occurrence of a SAE.
Time frame: up to the moment haemostasis has been achieved
Procedural complications, defined as any adverse event
Time frame: from start of the procedure up to the moment haemostasis has been achieved
Ankle Brachial Index.
Time frame: discharge and 12 months
Treadmill test.
Time frame: 12 months
Restenosis measured by Duplex Ultrasound.
Time frame: 12 months
Quality of Life assessment.
Time frame: baseline, 6, and 12 months post procedure
This study is terminated, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Cordis Corporation