S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease

NCT00739102 | Completed Results DMC

• 1 other identifier: P05-6201
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery disease.

Conditions

Superficial Femoral Artery Disease

Keywords

Superficial Femoral Artery; Nitinol Self-Expandable Stent System

Outcome Measures

Primary Outcomes (2)

• 12-month Primary Patency Rate

  Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \>50% with a peak systolic velocity ratio \>2.0 as measured by Duplex ultrasound.

  12 months

• Primary Safety Endpoint

  Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and \>50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of \>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.

  30 days

Secondary Outcomes (11)

• Death Rate at 30-day Post Procedure

  30 days

• Death at 12-month Post Procedure

  12 months

• Index Limb Amputation at 30-day Follow up

  30 day

• Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure

  30 days

• Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure

  12 months

Study Arms (1)

1

EXPERIMENTAL

S.M.A.R.T.® Nitinol Self-Expandable Stent System

Device: S.M.A.R.T. ® Stent

Interventions

S.M.A.R.T. ® Stent DEVICE

The Cordis S.M.A.R.T.® Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 30 years
• For women of child bearing potential, a pregnancy test within 7 days prior to index procedure (the test results must be negative to be eligible).
• Symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4) with a resting or exercise ABI \</= 0.8.
• A single superficial femoral artery lesion with \> 50% stenosis or total occlusion.
• Stenotic lesion or occluded length within the same vessel (one long or multiple serial lesions) \>/= 4.0 cm to \</= 15.0 cm, by visual estimate. The stenosis must be treatable with no more than two stents, minimizing the stent overlap whose combined length \</= 170 mm.
• Reference vessel diameter (RVD) \>/= 4.0 mm and \</= 6.0 mm by visual assessment.
• All lesions are to be located at least three centimeters proximal to the superior edge of the patella.
• Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\< 50% stenosis) to the ankle or foot.
• The guidewire is across the target lesion(s) and located intraluminally within the distal vessel.
• Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \> 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as \<30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, if the peak to peak pressure gradient across the inflow lesion is \</= 20mmHg and the peak to peak pressure gradient across the SFA target lesion is \>/= 20mmHg, then the patient will be included in the study.
• A patient with bilateral obstructive SFA disease is eligible for enrollment into the study.
• Eligibility for standard surgical repair, if necessary.
• A patient who requires a coronary intervention, should have it performed at least 7 days prior to the treatment of the target lesion.
• Patient or authorized representative must provide written informed consent and written HIPAA authorization prior to initiation of study procedures.
• Patient must be willing to comply with the specified follow-up evaluation schedule.

You may not qualify if:

• Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days.
• Receiving dialysis or immunosuppressant therapy.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure where complete resolution of the thrombus was not achieved.
• Recent stroke within past 90 days.
• Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery within past 5 years.
• Required stent placement via a popliteal approach.
• Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation.
• Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as severe calcification which is resistant to stenting, or for in-stent restenosis.
• Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
• Previously deployed stent within the SFA of the target limb.
• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.
• Presence of thrombus prior to crossing the lesion
• Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
• Serum creatinine level \>/= 2.5 mg/dl at time of screening visit
• Known or suspected active infection at the time of the procedure

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Results Point of Contact

• Title: Patricia Schleckser, Director Medical Affairs
• Organization: Cordis Corporation, a Johnson & Johnson company

pschleck@its.jnj.com

908-541-4564

Study Officials

• William Gray, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: April 1, 2013
• Last Updated: April 17, 2014
• Results First Posted: September 18, 2013

Record last verified: 2014-03

Locations

US (1)