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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02599389
Other study ID # CHUBX 2014/40
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 2015
Est. completion date May 2020

Study information

Verified date November 2019
Source University Hospital, Bordeaux
Contact Eric DUCASSE, MD, PhD
Phone +335 56 79 55 25
Email eric.ducasse@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 222
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Drug-coated balloons

Excimer Laser


Locations

Country Name City State
France Clinique Rhône Durance Avignon
France Centre Hospitalier Universitaire de Besançon Besançon
France University Hospital of Bordeaux - Hospital Pellegrin Bordeaux
France Centre Hospitalier Universitaire de Clermont-Ferrand Clermont-Ferrand
France Centre Hospitalier Universitaire de Dijon Dijon
France Hospices Civils de Lyon Lyon
France Hôpital Timone Adultes Marseille
France Centre Hospitalier Universitaire de Nantes Nantes
France Polyclinique Les Fleurs Ollioules
France Hôpital Européen Georges Pompidou - AP-HP de Paris Paris
France Centre Hospitalier Universitaire de Rennes Rennes
France Clinique de L'Europe Rouen
France Centre Hospitalier Universitaire de St Etienne St Etienne
France Centre Hospitalier Universitaire de Strasbourg Strasbourg
France Clinique Pasteur Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incremental cost per Qaly gained at 18 months 18 months after angioplasty
Primary Incremental cost per avoided stenosis relapse at 18 months 18 months after angioplasty
Secondary 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
Secondary 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
Secondary Improvement in the walking procedure Improvement in the walking procedure performing by Strandness test Before and 12 months after angioplasty
Secondary 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
Secondary Systolic blood pressure Index Index :ratio of brachial pressure and compressible leg artery pressure 6 months, 12 months and 18 months after angioplasty
Secondary new treatment for the treated lesion 6 months, 12 months and 18 months after angioplasty
Secondary revascularization, with restenosis of the treated lesion 6 months, 12 months and 18 months after angioplasty
Secondary recurrence of clinical symptoms 6 months, 12 months and 18 months after angioplasty
Secondary Blood ultrasonic doppler velocimetry 6 months, 12 months and 18 months after angioplasty
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