Peripheral Arterial DiseasePLAISIRNCT01587482

PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

An observational study of Peripheral Arterial Disease, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: PacLitaxel Eluting Balloon Application
Type of treatment: Surgery or procedure
How many people: 53 participants
Where: 1 siteFrance
Study dates: Dec 2011to Jan 2015
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: From December 2011 to December 2012 at 13 hospitals in France, we will include patients with symptomatic atherosclerotic lesions related to superficial femoral artery in-stent restenosis to undergo endovascular repair by paclitaxel drug eluting balloon. 100 patients will be included.

Who may be able to join

Age ≥18 years old
Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)
Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery)

Show all 10Show fewer

The target lesion must no extend beyond the stent margin
Successful crossing of the target lesion, inflow and outflow lesions with a guidewire
Patient belongs to the French health care system
Written informed consent

Who cannot join

No atheromatous disease
Asymptomatic lesion
Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
Acute limb ischemia
Patient on oral anticoagulation therapy
Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc.

Show all 10Show fewer

Life expectancy < 1 year
Patient involved in another trial
Refusing patient
Pregnancy

Trial locations and contacts

1 site in 1 country.

France1 site

Nantes University Hospital
Nantes, 44093

Other trials in France

About this study

Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.

Conditions: Peripheral Arterial Disease
Being tested: PacLitaxel Eluting Balloon Application
Keywords: Superficial femoral artery, endovascular, Drug eluting balloon, Paclitaxel
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PacLitaxel Eluting Balloon ApplicationProcedure or surgery
Stenting is a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR.

Study groups in NCT01587482
Study group	Role	What they receive
drug eluting balloon		In this observationnal study, the intervention of interest is the use of drug eluting balloon in stent restenosis. Only the treated patients were included in this cohort. Receives: Procedure: PacLitaxel Eluting Balloon Application

What is being measured

The primary outcome is the main question the study is designed to answer.

Target Lesion Revascularization (TLR)
Measured: at 1 year

Secondary outcomes (11)

Major Adverse Events through
Measured: at 1 year
Target extremity revascularization (TER)
Measured: at 1, 3, 6, 9, 12 and 18 months after surgery
clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization
to assess primary maintenance of clinical improvement
Measured: at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index without Target Lesion Revascularization
to assess primary patency
Measured: at 1, 3, 6, 9, 12 and 18 months
Quality of life assessment by EQ5D questionnaire
Measured: at 1, 3, 6, 9, 12 and 18 mois after surgery
post-angioplasty restenosis
Measured: at 1, 3, 6, 9, 12 and18 months after surgery
drug relief success without balloon break
Measured: during surgery
Length of hospitalization stay
Measured: at 1 year
clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery
to assess secondary maintenance of clinical improvement
Measured: at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index
to assess secondary patency
Measured: at 1 year
intra-stent restenosis
significant whether restenosis >50% and peak systolic velocity index > 2.4
Measured: at 1, 3, 6, 9, 12 and 18 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jan 2015

First posted30 Apr 2012 (estimated)
Study startDec 2011
Primary completionDec 2012
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
More trials run by Nantes University HospitalThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01587482
Sponsor's protocol ID: PROG/11/79
Acronym: PLAISIR
Status last verified: May 2016
First submitted: 15 Feb 2012
Last updated: 20 May 2016
Results posted: No
Data monitoring committee: No

Publications

Bague N, Julia P, Sauguet A, Pernes JM, Chatelard P, Garbe JF, Penillon S, Cardon JM, Commeau P, Planche O, Guyomarch B, Goueffic Y. Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):106-113. doi: 10.1016/j.ejvs.2016.10.002. Epub 2016 Nov 24.
PubMed 27890526

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis
ClinicalTrials.gov ID: NCT01587482
Acronym / sponsor ID: PLAISIR / PROG/11/79
Conditions: Peripheral Arterial Disease
Keywords: Superficial femoral artery, endovascular, Drug eluting balloon, Paclitaxel
Study type: Observational
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Nantes University HospitalUniversity, hospital or other
Study start: Dec 2011
Primary completion: Dec 2012 (actual)
Study completion: Jan 2015 (actual)
First posted: 30 Apr 2012 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
drug eluting balloon	–	Procedure: PacLitaxel Eluting Balloon ApplicationIn this observationnal study, the intervention of interest is the use of drug eluting balloon in stent restenosis. Only the treated patients were included in this cohort.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: From December 2011 to December 2012 at 13 hospitals in France, we will include patients with symptomatic atherosclerotic lesions related to superficial femoral artery in-stent restenosis to undergo endovascular repair by paclitaxel drug eluting balloon. 100 patients will be included.

Key inclusion criteria (10 listed)

Age ≥18 years old
Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)

Key exclusion criteria (10 listed)

No atheromatous disease
Asymptomatic lesion
Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
Acute limb ischemia
Patient on oral anticoagulation 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
PacLitaxel Eluting Balloon ApplicationStenting is a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR.	Procedure or surgery	drug eluting balloon

Primary outcome

Target Lesion Revascularization (TLR)
Time frame: at 1 year

11 secondary outcomes

Major Adverse Events through
Time frame: at 1 year
Target extremity revascularization (TER)
Time frame: at 1, 3, 6, 9, 12 and 18 months after surgery
clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization
Time frame: at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index without Target Lesion Revascularization
Time frame: at 1, 3, 6, 9, 12 and 18 months
Quality of life assessment by EQ5D questionnaire
Time frame: at 1, 3, 6, 9, 12 and 18 mois after surgery
post-angioplasty restenosis
Time frame: at 1, 3, 6, 9, 12 and18 months after surgery
drug relief success without balloon break
Time frame: during surgery
Length of hospitalization stay
Time frame: at 1 year
clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery
Time frame: at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index
Time frame: at 1 year
intra-stent restenosis
Time frame: at 1, 3, 6, 9, 12 and 18 months after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
Derived from this study: PubMed 27890526Bague N, Julia P, Sauguet A, Pernes JM, Chatelard P, Garbe JF, Penillon S, Cardon JM, Commeau P, Planche O, Guyomarch B, Goueffic Y. Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):106-113. doi: 10.1016/j.ejvs.2016.10.002. Epub 2016 Nov 24.

Related trials for Peripheral Arterial Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

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.

Thierry Reix, PU-PH principal investigator

Amiens's Univeristy Hospital

Eric Ducasse, PU-PH principal investigator

Pellegrin's University Hospital

Patrick Lermusiaux, PU-PH principal investigator

Lyon's University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Nantes University Hospital at 1 site in France.

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 10 inclusion and 10 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: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Revascularization (TLR) (time frame: at 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01587482, which also lists 1 linked publication.

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 20 May 2016.