Clinical trial NCT00309595: The Study to Compare SMART Nitinol Stent and Balloon Angioplasty
Official title: A Multi-Center Prospective, Randomized, Two-Arm Clinical Investigation of the Cordis SMARTTM 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: Superficial Femoral Artery Occlusions
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 50
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: This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.

Detailed description: The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. 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. At least one calf vessel must be patent. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm.

Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty.

Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.

This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).

Eligibility criteria: Inclusion Criteria:

1. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months;
2. One de-novo or restenotic SFA with an occluded length \> 5 to \< 22 cm;
3. Patent popliteal artery on the index side (without \> 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without \> 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.

Exclusion Criteria:

1. Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;
2. Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;
3. Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.

Primary outcomes:
measure: Binary restenosis by Duplex Ultrasound.
timeFrame: 1 year
Secondary outcomes:
measure: Technical success defined as a successful access and deployment of the device with recanalization.
timeFrame: at the time of deployment
measure: Procedural complications.
timeFrame: up to the moment the catheter sheath introducer has been removed
measure: Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE).
timeFrame: up to the catheter sheath introducer has been removed
measure: Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.
timeFrame: 1, 6 and 12 months
measure: Ankle Brachial Index (ABI).
timeFrame: discharge, 1, 6 and 12 months
measure: Restenosis measured by Duplex sonography.
timeFrame: 1, 6 and 12 months
measure: Target Lesion revascularisation (TLR).
timeFrame: 1 year
measure: Target Vessel revascularisation (TVR).
timeFrame: 1 year
measure: Target Limb revascularisation.
timeFrame: 1 year
measure: The number of revascularisations in both limbs.
timeFrame: 1 year
measure: Clinical categorization of chronic limb ischemia by means of the Rutherford classification.
timeFrame: 1, 6 and 12 months
measure: Pain free and absolute walking distance (treadmill testing) as compared to baseline testing.
timeFrame: 1 and 12 months post index procedure
measure: Amputation of the index limb.
timeFrame: 1 year
measure: Cardiovascular events (ACS, TIA, stroke, vascular death).
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Univeristy Hospital Bern
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern
name: Iris Baumgartner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leitende Ärztin Angiologie - University Hospital Zurich
name: Beatrice Amann, MD
role: PRINCIPAL_INVESTIGATOR
References: