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

April 5, 2012 updated by: SIABLIS DIMITRIOS, University of Patras

Balloon Angioplasty Versus Self-expanding Stent for Recanalization of Chronic Total Occlusions 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Greece
      • Heraklion, Greece
        • Recruiting
        • Heraklion University Hospital
        • Contact:
        • Principal Investigator:
          • Dimitrios Tsetis, MD,PhD
    • Achaia
      • Rion, Achaia, Greece, 26500
        • Recruiting
        • Patras University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Konstadinos Katsanos, MD,PhD
        • Sub-Investigator:
          • Athanasios Diamantopoulos, MD
    • Attiki
      • Athens, Attiki, Greece, 12461
        • Recruiting
        • Attikon University Hospital
        • Contact:
        • Principal Investigator:
          • Elias Broutzos, MD,PhD
  • Italy
      • Varese, Italy, I21100
        • Recruiting
        • Insubria University Hospital
        • Contact:
        • Principal Investigator:
          • Gianpaolo Carrafiello, MD,PhD
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Guy's and St Thomas' Hospitals, NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Tarun Sabharwal, FRCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary patency
Time Frame: Immediate and at 6 months follow-up
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
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from major adverse event
Time Frame: 30-days to 1year
30-days, 6 months and 1 year freedom from all causes of death, index limb amputation and target vessel recanalization (TVR)
30-days to 1year
Binary vessel restenosis
Time Frame: 6 months to 1 year
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
6 months to 1 year
Secondary vessel patency
Time Frame: Immediate to 1 year
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
Immediate to 1 year
AHA Clinical Improvement Score
Time Frame: At 3 months, 6 months and 1 year
At 3 months, 6 months and 1 year
QALY estimation
Time Frame: At 6 months and 1 year
QALY estimation of the two study methods with the use of the SF36 questionnaire
At 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Patras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 30357/2-12-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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