Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Angioplasty, Balloon

Intervention / Treatment
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* Device: Drug-coated balloons
* Device: Excimer Laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard balloon<br>Angioplasty with use of standard balloons | |
| Experimental: Drug-coated balloons<br>Angioplasty with use of drug-coated balloons | Device: Drug-coated balloons<br> <br> * Other names: In.Pact (Medtronic);|
| Experimental: Drug-coated balloons and laser<br>Angioplasty with use of drug-coated balloons in association with Excimer Laser | Device: Drug-coated balloons<br> <br> * Other names: In.Pact (Medtronic);Device: Excimer Laser<br> <br> * Other names: SPECTRANETICS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost per Qaly gained at 18 months |  | 18 months after angioplasty | 
| Incremental cost per avoided stenosis relapse at 18 months |  | 18 months after angioplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New In-stent restenosis during follow-up | No recurrence of in-stent restenosis > 50% during follow-up with doppler . The three treatment groups are compared. | 1 month, 6 months, 12 months and 18 months after angioplasty | 
| A major adverse event | Absence of major event during follow-up as death, lower limb amputation or lack of required revascularization. | 1 month, 6 months, 12 months and 18 months after angioplasty | 
| Improvement in the walking procedure | Improvement in the walking procedure performing by Strandness test | Before and 12 months after angioplasty | 
| Clinical improvement | Clinical improvement by the Rutherford classification at 6, 12 and 18 months. This improvement is objectified by a decrease in category 1 or several classes. | 6 months, 12 months and 18 months after angioplasty | 
| Systolic blood pressure Index | Index :ratio of brachial pressure and compressible leg artery pressure | 6 months, 12 months and 18 months after angioplasty | 
| new treatment for the treated lesion |  | 6 months, 12 months and 18 months after angioplasty | 
| revascularization, with restenosis of the treated lesion |  | 6 months, 12 months and 18 months after angioplasty | 
| recurrence of clinical symptoms |  | 6 months, 12 months and 18 months after angioplasty | 
| Blood ultrasonic doppler velocimetry |  | 6 months, 12 months and 18 months after angioplasty | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in-stent restenosis; drug-coated balloons; Excimer Laser, cost effectiveness study, quality of life