Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00739102
Other study ID # P05-6201
Secondary ID
Status Completed
Phase N/A
First received August 20, 2008
Last updated March 28, 2014
Start date August 2008
Est. completion date April 2013

Study information

Verified date March 2014
Source Cordis Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date April 2013
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- Bleeding diathesis

- Presence of an aortic, iliac or femoral artificial graft

- Life expectancy less than one year, or any other factors preventing clinical followup.

- Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of index procedure

- In-stent restenotic lesions at time of procedures.

- Restenotic lesion that had previously been treated by atherectomy, laser, or cryoplasty within 90 days of the index procedure.

- Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.

- Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.

- Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.

- Patient has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study. Interventional procedures performed to the ipsilateral iliac artery to provide access will be allowed.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Superficial Femoral Artery Disease

Intervention

Device:
S.M.A.R.T. ® Stent
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.

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 Yes
Secondary Death Rate at 30-day Post Procedure 30 days Yes
Secondary Death at 12-month Post Procedure 12 months Yes
Secondary Index Limb Amputation at 30-day Follow up Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up. 30 day Yes
Secondary Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) = 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel 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 Yes
Secondary Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) = 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel 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. 12 months Yes
Secondary Stent Fracture at 12-month Follow Up Stent fracture was assessed by x-ray evaluation. 12 months Yes
Secondary Index Limb Ischemia at 6-month Follow up Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. 6 months Yes
Secondary Index Limb Ischemia at 12-month Follow up Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. 12 months Yes
Secondary Rutherford/Becker Classification at 30-day Follow Up The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:
Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease
Stage 1 - Mild claudication
Stage 2 - Moderate claudication
Stage 3 - Severe claudication
Stage 4 - Ischemic rest pain
Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia
Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
30 days Yes
Secondary Rutherford / Becker Classification Category at 12-month Follow Up 12 months Yes
Secondary Major Adverse Events at 12-month Post Procedure Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage. 12 months Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04546477 - Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease N/A
Completed NCT01230229 - Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A