The Study to Compare SMART Nitinol Stent and Balloon Angioplasty (SIT-UP)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00309595
First received: March 31, 2006
Last updated: June 10, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Superficial Femoral Artery Occlusions
Device: stent
Device: balloon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Binary restenosis by Duplex Ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Enrollment: 50
Study Start Date: December 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cordis SMART™ nitinol self expandable stent
Device: stent
Cordis SMART™ Nitinol Stent System
Active Comparator: 2
balloon
Device: balloon
balloon angioplasty

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309595

Locations
Switzerland
Univeristy Hospital Bern
Bern, Switzerland, CH-3010
University Hospital Zurich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Iris Baumgartner, MD Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern
Principal Investigator: Beatrice Amann, MD Leitende Ärztin Angiologie - University Hospital Zurich
  More Information

No publications provided

Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis
ClinicalTrials.gov Identifier: NCT00309595     History of Changes
Other Study ID Numbers: EE04-03
Study First Received: March 31, 2006
Last Updated: June 10, 2009
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014