Clinical trial NCT02599389: Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis
Official title: Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-Excimer in Association With Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Angioplasty, Balloon
Keywords: in-stent restenosis; drug-coated balloons; Excimer Laser, cost effectiveness study, quality of life
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard angioplasty using plain balloons. INTACT study main objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent restenosis by comparing these two innovative strategies and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.

Detailed description: The publication show that there is probably an effectiveness gradient (expressed as a proportion of patients with in-stent restenosis a 18 months after the intervention of the first stenosis reduction): standard balloons would be less effective than active balloons themselves less effective than in combination with the excimer laser. Reducing the risk of In-Stent Restenosis has major implications for the treatment of patients because it reduces the use of arterial bypass or amputation, if unable to perform revascularization.

Based on these promising results of efficiency, we can hypothesize that the active balloons in combination with the Excimer laser would improve the quality of life of patients while reducing the cost of their treatment, this compared to only assets balloons. This same improvement in quality of life with reduced costs of care would be observed for only assets compared to standard balloons. In health economic terms, it is therefore likely that the strategy combining assets balloons and Excimer laser is dominant over assets balloons themselves dominant over standard balloons.

Eligibility criteria: Inclusion Criteria:

* Patient of age \> 18 years
* Patient with previously peripheral implanted stent(s) located in or extending to the popliteal artery
* Patient who received this stent between 3-36 months before inclusion
* Patient with one or more in-stent restenosis lesion(s) \> 70% in the same arterial segment in association with clinical symptoms of claudication or an critical limb ischemia with Rutherford classification of 2, 3, 4 or 5
* Reference vessel diameter between 4 and 7 mm
* Patient affiliated to a social security regimen
* EC-approved consent form signed by the participant and the investigator (must be signed prior initiation of any study related intervention)

Exclusion Criteria:

* Life expectancy \>18 months
* Patient already included in this study (recruitment of the contralateral leg is not allowed)
* Patient contraindicated for the use of antiplatelet therapy
* Pregnant or breast-feeding women
* Patient with a target limb infection being treated
* Patient with a procoagulant blood disease
* Patient with history of contrast agents allergies
* Patient with intolerance to paclitaxel
* Patient with severe renal impairment (GFR \<30 ml / min / 1.73 m²) or patient with a creatinine clearance \<15 ml / min
* External compression of previously implanted stent
* Patient participating in any clinical trial using another investigational drug or product which could interfere with the interpretation of the trial results.
* Patient under trusteeship or guardianship

Angiographic exclusion criteria :

* Inflow (above) severe lesion \>70% or occlusion untreated satisfactorily (residual lesion\> 50%) before the management of the target lesion
* Perforation, dissection or lesions on the arterial network access requiring an assumption prior to randomization
* Stent fracture grade 4 or 5 at the target lesion

Primary outcomes:
measure: Incremental cost per Qaly gained at 18 months
timeFrame: 18 months after angioplasty
measure: Incremental cost per avoided stenosis relapse at 18 months
timeFrame: 18 months after angioplasty
Secondary outcomes:
measure: New In-stent restenosis during follow-up
timeFrame: 1 month, 6 months, 12 months and 18 months after angioplasty
measure: A major adverse event
timeFrame: 1 month, 6 months, 12 months and 18 months after angioplasty
measure: Improvement in the walking procedure
timeFrame: Before and 12 months after angioplasty
measure: Clinical improvement
timeFrame: 6 months, 12 months and 18 months after angioplasty
measure: Systolic blood pressure Index
timeFrame: 6 months, 12 months and 18 months after angioplasty
measure: new treatment for the treated lesion
timeFrame: 6 months, 12 months and 18 months after angioplasty
measure: revascularization, with restenosis of the treated lesion
timeFrame: 6 months, 12 months and 18 months after angioplasty
measure: recurrence of clinical symptoms
timeFrame: 6 months, 12 months and 18 months after angioplasty
measure: Blood ultrasonic doppler velocimetry
timeFrame: 6 months, 12 months and 18 months after angioplasty
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Hospital Pellegrin
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital Timone Adultes
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - AP-HP de Paris
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Rouen
country: France
facility: Clinique de L'Europe
city: St Etienne
country: France
facility: Centre Hospitalier Universitaire de St Etienne
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: University Hospital, Bordeaux
name: Eric DUCASSE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: