The Study to Compare SMART Nitinol Stent and Balloon Angioplasty

Superficial Femoral Artery Occlusions Clinical Trial

— SIT-UP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309595
• Other study ID #: EE04-03
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2006
• Last updated: June 10, 2009
• Start date: December 2005
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

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
• Superficial Femoral Artery Occlusions

Intervention

Device:
• stent
Cordis SMART™ Nitinol Stent System
• balloon
balloon angioplasty

Locations

Country	Name	City	State
Switzerland	Univeristy Hospital Bern	Bern
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary restenosis by Duplex Ultrasound.		1 year	Yes
Secondary	Technical success defined as a successful access and deployment of the device with recanalization.		at the time of deployment	No
Secondary	Procedural complications.		up to the moment the catheter sheath introducer has been removed	Yes
Secondary	Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE).		up to the catheter sheath introducer has been removed	Yes
Secondary	Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.		1, 6 and 12 months	Yes
Secondary	Ankle Brachial Index (ABI).		discharge, 1, 6 and 12 months	Yes
Secondary	Restenosis measured by Duplex sonography.		1, 6 and 12 months	Yes
Secondary	Target Lesion revascularisation (TLR).		1 year	Yes
Secondary	Target Vessel revascularisation (TVR).		1 year	Yes
Secondary	Target Limb revascularisation.		1 year	Yes
Secondary	The number of revascularisations in both limbs.		1 year	Yes
Secondary	Clinical categorization of chronic limb ischemia by means of the Rutherford classification.		1, 6 and 12 months	Yes
Secondary	Pain free and absolute walking distance (treadmill testing) as compared to baseline testing.		1 and 12 months post index procedure	Yes
Secondary	Amputation of the index limb.		1 year	Yes
Secondary	Cardiovascular events (ACS, TIA, stroke, vascular death).		1 year	Yes