Trial record 2 of 197 for:    Open Studies | angioplasty

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

This study is currently recruiting participants.
Verified December 2010 by University of Patras
Sponsor:
Information provided by (Responsible Party):
SIABLIS DIMITRIOS, University of Patras
ClinicalTrials.gov Identifier:
NCT01268722
First received: December 2, 2010
Last updated: April 5, 2012
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Chronic Total Occlusion of Artery of the Extremities
Device: Balloon angioplasty
Device: Primary stenting
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon Angioplasty Versus Self-expanding Stent for Recanalization of Chronic Total Occlusions of the Femoral Artery

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Primary patency [ Time Frame: Immediate and at 6 months follow-up ] [ Designated as safety issue: No ]
    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

  • Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Freedom from major adverse event [ Time Frame: 30-days to 1year ] [ Designated as safety issue: Yes ]
    30-days, 6 months and 1 year freedom from all causes of death, index limb amputation and target vessel recanalization (TVR)

  • Binary vessel restenosis [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: No ]
    6-month and 1-year binary vessel restenosis (>50%) defined by Duplex (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5), CTA, MRA or DSA according to well-established radiological criteria

  • Secondary vessel patency [ Time Frame: Immediate to 1 year ] [ Designated as safety issue: No ]
    Secondary patency up to 12 months follow-up defined as no significant reduction of flow detectable by vascular imaging through the index lesion following the loss of primary patency

  • AHA Clinical Improvement Score [ Time Frame: At 3 months, 6 months and 1 year ] [ Designated as safety issue: Yes ]
  • QALY estimation [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: No ]
    QALY estimation of the two study methods with the use of the SF36 questionnaire


Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Balloon Device: Balloon angioplasty
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
Other Names:
  • Percutaneous angioplasty
  • Balloon dilatation
Experimental: Stent Device: Primary stenting
This arm will include patients randomized to undergo primary stenting of the femoropopliteal chronic total occlusion
Other Names:
  • Self-expandable
  • Nitinol stents

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268722

Contacts
Contact: Dimitrios Siablis, MD, PhD 2613603219 ext +30 siablis@upatras.gr
Contact: Dimitrios Karnabatidis, MD, PhD 2613603218 ext +30 karnaby@med.upatras.gr

Locations
Greece
Patras University Hospital Recruiting
Rion, Achaia, Greece, 26500
Contact: Dimitrios Siablis, MD,PhD    2613603219 ext +30    siablis@upatras.gr   
Contact: Dimitrios Karnabatidis, MD,PhD    2613603218 ext +30    karnaby@med.upatras.gr   
Sub-Investigator: Konstadinos Katsanos, MD,PhD         
Sub-Investigator: Stavros Spiliopoulos, MD         
Sub-Investigator: Athanasios Diamantopoulos, MD         
Attikon University Hospital Recruiting
Athens, Attiki, Greece, 12461
Contact: Elias Brountzos, MD,PhD    2105831810 ext +30    ebrountz@med.uoa.gr   
Principal Investigator: Elias Broutzos, MD,PhD         
Heraklion University Hospital Recruiting
Heraklion, Greece
Contact: Dimitrios Tsetis, MD,PhD       tsetis@med.uoc.gr   
Principal Investigator: Dimitrios Tsetis, MD,PhD         
Italy
Insubria University Hospital Recruiting
Varese, Italy, I21100
Contact: Gianpaolo Carrafiello, MD,PhD    0332 278763 ext +39    gianpaolo.carrafiello@unisubria.it   
Principal Investigator: Gianpaolo Carrafiello, MD,PhD         
United Kingdom
Guy's and St Thomas' Hospitals, NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Tarun Sabharwal, FRCR       tarun_sabharwal@yahoo.co.uk   
Principal Investigator: Tarun Sabharwal, FRCR         
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Dimitrios Siablis, MD, PhD Patras University Hospital
  More Information

No publications provided

Responsible Party: SIABLIS DIMITRIOS, Professor of Radiology, University of Patras
ClinicalTrials.gov Identifier: NCT01268722     History of Changes
Other Study ID Numbers: 30357/2-12-2010
Study First Received: December 2, 2010
Last Updated: April 5, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Nitinol Stent
Balloon angioplasty
Chronic total occlusions
Femoropopliteal

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

ClinicalTrials.gov processed this record on April 17, 2014