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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Angioplasty, Balloon
• Intervention / Treatment: Device: Drug-coated balloons; Device: Excimer Laser

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.

• Study Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Recruiting
    • Clinique Rhône Durance
    • Contact: Jérôme BRUNET, MD; Phone Number: +334 90 14 81 90; Email: jeromebrunet2@wanadoo.fr
  • Besançon, France, 25030
    • Recruiting
    • Centre Hospitalier Universitaire de Besancon
    • Contact: Simon RINCKENBACH, MD, PhD; Phone Number: +333 81 66 80 52; Email: simon.rinckenbach@univ-fcomte.fr
  • Bordeaux, France, 33000
    • Recruiting
    • University Hospital of Bordeaux - Hospital Pellegrin
    • Contact: Eric DUCASSE, MD, PhD; Phone Number: +335 56 79 55 25; Email: eric.ducasse@chu-bordeaux.fr
    • Contact: Olivier PERIOT; Phone Number: +335 57 82 04 59; Email: olivier.periot@chu-bordeaux.fr
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • Centre Hospitalier Universitaire de Clermont-Ferrand
    • Contact: Eugenio ROSSET, MD, PhD; Phone Number: +334 73 75 15 10; Email: erosset@chu-clermontferrand.fr
  • Dijon, France, 21079
    • Recruiting
    • Centre Hospitalier Universitaire De Dijon
    • Contact: Eric STEINMETZ, MD, PhD; Phone Number: +333 80 29 33 85; Email: eric.steinmetz@chu-dijon.fr
  • Lyon, France, 69000
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Patrick LERMUSIAUX, MD, PhD; Phone Number: +334 72 11 68 34; Email: patrick.lermusiaux@chu-lyon.fr
  • Marseille, France, 130005
    • Withdrawn
    • Hopital Timone Adultes
  • Nantes, France, 44093
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes
    • Contact: Yann GOUEFFIC, MD, PhD; Phone Number: +332 40 16 50 93; Email: yann.goueffic@chu-nantes.fr
  • Ollioules, France, 83190
    • Recruiting
    • Polyclinique Les Fleurs
    • Contact: Philippe COMMEAU, MD, PhD; Phone Number: +334 94 06 98 82; Email: p.commeau@wanadoo.fr
  • Paris, France, 75015
    • Recruiting
    • Hôpital Européen Georges Pompidou - AP-HP de Paris
    • Contact: Marc SAPOVAL, MD, PhD; Phone Number: +331 56 09 37 40; Email: marc.sapoval2@egp.aphp.fr
  • Rennes, France, 35033
    • Withdrawn
    • Centre Hospitalier Universitaire de Rennes
  • Rouen, France, 76100
    • Recruiting
    • Clinique de l'Europe
    • Contact: Jean SABATIER, MD; Phone Number: +332 32 18 12 76; Email: j.sabatier@clinique-europe.com
  • St Etienne, France, 42055
    • Recruiting
    • Centre hospitalier universitaire de St Etienne
    • Contact: Jean-Pierre FAVRE, MD, PhD; Phone Number: +334 77 82 83 35; Email: j.pierre.favre@chu-st-etienne.fr
  • Strasbourg, France, 67091
    • Recruiting
    • Centre Hospitalier Universitaire de Strasbourg
    • Contact: Nabil CHAKFE, MD, PhD; Phone Number: +333 69 55 08 88; Email: nabil.chakfe@chru-strasbourg.fr
  • Toulouse, France, 31076
    • Recruiting
    • Clinique Pasteur
    • Contact: Antoine SAUGUET, MD; Phone Number: +335 62 21 16 99; Email: asauguet@clinique-pasteur.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Antoine BENARD, MD, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux; Principal Investigator: Eric DUCASSE, MD, PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 6, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: in-stent restenosis; drug-coated balloons; Excimer Laser, cost effectiveness study, quality of life
• Other Study ID Numbers: CHUBX 2014/40