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.
Trial summary
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). Read more about this study
- 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)
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- 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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Reix, PU-PH, Principal investigator, Amiens's Univeristy HospitalEric Ducasse, PU-PH, Principal investigator, Pellegrin's University HospitalPatrick Lermusiaux, PU-PH, Principal investigator, Lyon's University HospitalJean-Marc Pernes, Practitioner, Principal investigator, Antony's private HospitalNicolas Louis, PH, Principal investigator, Le Raincy-Montfermeuil HospitalAntoine Sauget, Practitioner, Principal investigator, Pasteur's private HospitalPhilippe Commeau, Practitioner, Principal investigator, Ollioules private HospitalJean-Noel Albertini, PU-PH, Principal investigator, St Etienne University Hospital
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
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.
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.
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.
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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.
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.