Chronic Total Occlusion of Artery of the ExtremitiesPhase 3FACTORYNCT01268722
Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions
A Phase 3 study testing Balloon angioplasty and Primary stenting in people with Chronic Total Occlusion of Artery of the Extremities, run by University of Patras at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- Balloon angioplasty and Primary stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Dec 2010to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Greece3 sites, 3 recruiting
- Recruiting
Attikon University Hospital
Athens, Attica, 12461
Elias Brountzos, MD,PhD, 2105831810 ext. +30, ebrountz@med.uoa.gr
Elias Broutzos, MD,PhD
- Recruiting
Heraklion University Hospital
Heraklion
Dimitrios Tsetis, MD,PhD, tsetis@med.uoc.gr
Dimitrios Tsetis, MD,PhD
- Recruiting
Patras University Hospital
Rio, Achaia, 26500
Dimitrios Siablis, MD,PhD, 2613603219 ext. +30, siablis@upatras.gr
Dimitrios Karnabatidis, MD,PhD, 2613603218 ext. +30, karnaby@med.upatras.gr
Italy1 site, 1 recruiting
- Recruiting
Insubria University Hospital
Varese, Varese, I21100
Gianpaolo Carrafiello, MD,PhD, 0332 278763 ext. +39, gianpaolo.carrafiello@unisubria.it
Gianpaolo Carrafiello, MD,PhD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Guy's and St Thomas' Hospitals, NHS Foundation Trust
London
Tarun Sabharwal, FRCR, tarun_sabharwal@yahoo.co.uk
Tarun Sabharwal, FRCR
About this study
Official title: 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.
Read the 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.
- Being tested
- Balloon angioplasty, Primary stenting
- Keywords
- Nitinol Stent, Balloon angioplasty, Chronic total occlusions, Femoropopliteal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon angioplastyDevice
Also called Percutaneous angioplasty, Balloon dilatation
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
Primary stentingDevice
Also called Self-expandable, Nitinol stents
This arm will include patients randomized to undergo primary stenting of the femoropopliteal chronic total occlusion
| Study group | Role | What they receive |
|---|---|---|
| Balloon | Active comparator | Not described Receives: Device: Balloon angioplasty |
| Stent | Experimental | Not described Receives: Device: Primary stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (5)
Freedom from major adverse event
30-days, 6 months and 1 year freedom from all causes of death, index limb amputation and target vessel recanalization (TVR)
Measured: 30-days to 1year
Binary vessel restenosis
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
Measured: 6 months to 1 year
Secondary vessel patency
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
Measured: Immediate to 1 year
AHA Clinical Improvement Score
Measured: At 3 months, 6 months and 1 year
QALY estimation
QALY estimation of the two study methods with the use of the SF36 questionnaire
Measured: At 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Artery of the ExtremitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SIABLIS DIMITRIOS, University of Patras
- Investigators
- Dimitrios Siablis, MD, PhD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268722
- Sponsor's protocol ID
- 30357/2-12-2010
- Acronym
- FACTORY
- Status last verified
- Dec 2010
- First submitted
- 2 Dec 2010
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Angioplasty Versus Self-expanding Stent for Recanalization of Chronic Total Occlusions of the Femoral Artery
- ClinicalTrials.gov ID
- NCT01268722
- Acronym / sponsor ID
- FACTORY / 30357/2-12-2010
- Keywords
- Nitinol Stent, Balloon angioplasty, Chronic total occlusions, Femoropopliteal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon | Active comparator | Device: Balloon angioplasty |
| Stent | Experimental | Device: Primary stenting |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon angioplastyAlso: Percutaneous angioplasty, Balloon dilatationThis arm will include patients randomized to undergo the treatment of a chronic total occlusion of the femoropopliteal artery with the use of balloon angioplasty | Device | Balloon |
| Primary stentingAlso: Self-expandable, Nitinol stentsThis arm will include patients randomized to undergo primary stenting of the femoropopliteal chronic total occlusion | Device | Stent |
Primary outcome
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
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
5 secondary outcomes
Freedom from major adverse event
Time frame: 30-days to 1year
Binary vessel restenosis
Time frame: 6 months to 1 year
Secondary vessel patency
Time frame: Immediate to 1 year
AHA Clinical Improvement Score
Time frame: At 3 months, 6 months and 1 year
QALY estimation
Time frame: At 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Siablis, MD, PhD principal investigator
University Hospital of Patras
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Balloon angioplasty and Primary stenting in people with Chronic Total Occlusion of Artery of the Extremities, run by University of Patras at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Siablis, MD, PhD (2613603219 ext. +30, siablis@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: Immediate and at 6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.