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PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis (PLAISIR)

19. maj 2016 opdateret af: Nantes University Hospital
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

53

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Nantes, Frankrig, 44093
        • Nantes University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Procedure: PacLitaxel Eluting Balloon Application
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Target Lesion Revascularization (TLR)
Tidsramme: at 1 year
at 1 year

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Efterforskere

  • Ledende efterforsker: Thierry Reix, PU-PH, Amiens's Univeristy Hospital
  • Ledende efterforsker: Eric Ducasse, PU-PH, Pellegrin's University Hospital
  • Ledende efterforsker: Patrick Lermusiaux, PU-PH, Lyon's University Hospital
  • Ledende efterforsker: Jean-Marc Pernes, Practitioner, Antony's private Hospital
  • Ledende efterforsker: Nicolas Louis, PH, Le Raincy-Montfermeuil Hospital
  • Ledende efterforsker: Antoine Sauget, Practitioner, Pasteur's private Hospital
  • Ledende efterforsker: Philippe Commeau, Practitioner, Ollioules private Hospital
  • Ledende efterforsker: Jean-Noel Albertini, PU-PH, St Etienne University Hospital
  • Ledende efterforsker: Olivier Planché, PH, Le Plessis-Robinson private hospital (CMC)
  • Ledende efterforsker: Max Amor, PH, Essey-les-Nancy Private hospital (Polyclinique Pasteur)
  • Ledende efterforsker: Jean-Marie Cardon, Dr, Nimes private Hospital (clinique des fransiscaines)
  • Ledende efterforsker: Alain Cardon, PH, Rennes's University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2011

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

15. februar 2012

Først indsendt, der opfyldte QC-kriterier

26. april 2012

Først opslået (Skøn)

30. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PROG/11/79

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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