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

University Hospital of Bordeaux

Status and phase: Unknown; Phase 3

Conditions: Angioplasty, Balloon

Treatments: Device: Drug-coated balloons; Device: Excimer Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02599389

CHUBX 2014/40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 3 patient groups

Standard balloon

No Intervention group

Description:

Angioplasty with use of standard balloons

Drug-coated balloons

Experimental group

Description:

Angioplasty with use of drug-coated balloons

Treatment:

Device: Drug-coated balloons

Drug-coated balloons and laser

Experimental group

Description:

Angioplasty with use of drug-coated balloons in association with Excimer Laser

Treatment:

Device: Excimer Laser

Device: Drug-coated balloons