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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00924-45 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard balloon | No Intervention | Angioplasty with use of standard balloons | |
| Drug-coated balloons | Experimental | Angioplasty with use of drug-coated balloons |
|
| Drug-coated balloons and laser | Experimental | Angioplasty with use of drug-coated balloons in association with Excimer Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-coated balloons | Device |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Eric DUCASSE, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Antoine BENARD, MD | Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Rhône Durance | Avignon | 84000 | France | |||
| Centre Hospitalier Universitaire de Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38659343 | Result | Ducasse E, Sapoval M, Brunet J, Commeau P, Goueffic Y, Sabatier J, Steinmetz E, Lermusiaux P, Rosset E, Caradu C. Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT). J Endovasc Ther. 2026 Feb;33(1):244-258. doi: 10.1177/15266028241248333. Epub 2024 Apr 24. |
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| Excimer Laser | Device |
|
|
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 |
| Besançon |
| 25030 |
| France |
| University Hospital of Bordeaux - Hospital Pellegrin | Bordeaux | 33000 | France |
| Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Universitaire de Dijon | Dijon | 21079 | France |
| Hospices Civils de Lyon | Lyon | 69000 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44093 | France |
| Polyclinique Les Fleurs | Ollioules | 83190 | France |
| Hôpital Européen Georges Pompidou - AP-HP de Paris | Paris | 75015 | France |
| Clinique de L'Europe | Rouen | 76100 | France |
| Centre Hospitalier Universitaire de St Etienne | Saint-Etienne | 42055 | France |
| Centre Hospitalier Universitaire de Strasbourg | Strasbourg | 67091 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| ID | Term |
|---|---|
| D054018 | Lasers, Excimer |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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