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

NCT01268722 | Unknown Phase 3 DMC

• 1 other identifier: 30357/2-12-2010
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 5

Brief Summary

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.

Conditions

Chronic Total Occlusion of Artery of the Extremities

Keywords

Nitinol Stent; Balloon angioplasty; Chronic total occlusions; Femoropopliteal

Outcome Measures

Primary Outcomes (2)

• Primary patency

  Primary patency after 6 months follow-up defined as no significant reduction of flow detectable by vascular imaging through the index lesion and without any further clinically driven target vessel revascularization performed in the interim

  Immediate and at 6 months follow-up

• Primary Patency

  Primary patency after 12 months follow-up defined as no significant reduction of flow detectable by vascular imaging through the index lesion and without any further clinically driven target vessel revascularization performed in the interim

  12 months

Secondary Outcomes (5)

• Freedom from major adverse event

  30-days to 1year

• Binary vessel restenosis

  6 months to 1 year

• Secondary vessel patency

  Immediate to 1 year

• AHA Clinical Improvement Score

  At 3 months, 6 months and 1 year

• QALY estimation

  At 6 months and 1 year

Study Arms (2)

Balloon

ACTIVE COMPARATOR

Device: Balloon angioplasty

Stent

EXPERIMENTAL

Device: Primary stenting

Interventions

Balloon angioplasty DEVICE

This arm will include patients randomized to undergo the treatment of a chronic total occlusion of the femoropopliteal artery with the use of balloon angioplasty

Also known as: Percutaneous angioplasty, Balloon dilatation

Balloon

Primary stenting DEVICE

This arm will include patients randomized to undergo primary stenting of the femoropopliteal chronic total occlusion

Also known as: Self-expandable, Nitinol stents

Stent

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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (5)

Patras University Hospital

Rio, Achaia, 26500, Greece

RECRUITING

Attikon University Hospital

Athens, Attica, 12461, Greece

RECRUITING

Heraklion University Hospital

Heraklion, Greece

RECRUITING

Insubria University Hospital

Varese, Varese, I21100, Italy

RECRUITING

Guy's and St Thomas' Hospitals, NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Interventions

Angioplasty, Balloon; Self Expandable Metallic Stents

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Dimitrios Siablis, MD, PhD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Siablis, MD, PhD

CONTACT

2613603219; siablis@upatras.gr

Dimitrios Karnabatidis, MD, PhD

CONTACT

2613603218; karnaby@med.upatras.gr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 31, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2016
• Last Updated: April 6, 2012

Record last verified: 2010-12

Locations

IT (1); GB (1); GR (3)