Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions (FACTORY)

University of Patras

Status and phase

Unknown

Phase 3

Conditions

Chronic Total Occlusion of Artery of the Extremities

Treatments

Device: Balloon angioplasty

Device: Primary stenting

Study type

Interventional

Funder types

Other

Identifiers

NCT01268722

30357/2-12-2010

Details and patient eligibility

About

This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year.

Full description

Primary placement of new-generation nitinol stents compared to plain old balloon angioplasty has shown encouraging long-term results in the femoropopliteal artery. However, there is complete lack of data about performance of new-generation nitinol stents in the treatment of chronic total occlusions (CTO) of the Femoral artery. This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year.

Enrollment

150 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >/= 30 years, both genders, no healthy volunteers
Negative pregnancy test for women of childbearing age
Symptomatic leg ischemia by Rutherford/Becker Classification (category 3, 4 or 5), i.e. lifestyle-limiting claudication or critical limb ischemia Single completely occluded de-novo superficial femoral artery lesion (femoral artery CTO target lesion)
Combined overall length of treatable occluded SFA lesion >/= 4.0 cm to </= 15.0 cm, by visual estimate. The occlusion must be treatable with no more than two stents, minimizing the stent overlap.
Randomization process before successful subintimal or intraluminal recanalization of the lesion in order to evaluate technical success
Use of re-entry devices at the discretion of the operator
All lesions are to be located at least three centimeters (3 cm) proximal to the superior edge of the patella
Reference vessel diameter (RVD) >/= 4.0 mm and </ 6.0 mm by visual assessment
At least 1 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
Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined > 50% stenosis of the iliac or common femoral artery) lesions must be successfully treated prior to treatment of the target lesion
Bilateral obstructive SFA disease is eligible for enrollment into the study
Patient or authorized representative must provide written informed consent prior to initiation of study procedures
Patient must be willing to comply with the specified follow-up protocol

Exclusion criteria

In-stent restenotic lesions (ISR occlusions)
Distal popliteal of 3-vessel tibial occlusion
Patients on hemodialysis because of heavily calcified vessels
Recent thrombophlebitis, uremia, or deep venous thrombus (within past 30 days)
Patients receiving dialysis or immunosuppressant therapy
Thrombolysis of the target vessel within 72 hours prior to the index procedure with residual intraluminal thrombi
Recent major stroke within the past 6 months
Aneurysmal disease of the aorta, iliac, femoral or popliteal arteries
Required stent placement across or within 0.5 cm of the femoral bifurcation
Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of a stent device if necessary
Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed
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 follow-up.
Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of 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.