Angioplasty, Balloon
Conditions
Keywords
in-stent restenosis; drug-coated balloons; Excimer Laser, cost effectiveness study, quality of life
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.
Interventions
DEVICEDrug-coated balloons
DEVICEExcimer Laser
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| New In-stent restenosis during follow-up | 1 month, 6 months, 12 months and 18 months after angioplasty | No recurrence of in-stent restenosis \> 50% during follow-up with doppler . The three treatment groups are compared. |
| A major adverse event | 1 month, 6 months, 12 months and 18 months after angioplasty | Absence of major event during follow-up as death, lower limb amputation or lack of required revascularization. |
| Improvement in the walking procedure | Before and 12 months after angioplasty | Improvement in the walking procedure performing by Strandness test |
| Clinical improvement | 6 months, 12 months and 18 months after angioplasty | 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. |
| Systolic blood pressure Index | 6 months, 12 months and 18 months after angioplasty | Index :ratio of brachial pressure and compressible leg artery pressure |
| 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 | — |
Countries
France
Contacts
Primary ContactEric DUCASSE, MD, PhD
Backup ContactOlivier PERIOT
Outcome results
None listed