NCT02599389

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

4.4 years

First QC Date

November 5, 2015

Last Update Submit

November 15, 2019

Conditions

Angioplasty, Balloon

Keywords

in-stent restenosis; drug-coated balloons; Excimer Laser, cost effectiveness study, quality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • New In-stent restenosis during follow-up

    1 month, 6 months, 12 months and 18 months after angioplasty

  • A major adverse event

    1 month, 6 months, 12 months and 18 months after angioplasty

  • Improvement in the walking procedure

    Before and 12 months after angioplasty

  • Clinical improvement

    6 months, 12 months and 18 months after angioplasty

  • Systolic blood pressure Index

    6 months, 12 months and 18 months after angioplasty

  • +4 more secondary outcomes

Study Arms (3)

Standard balloon

NO INTERVENTION

Angioplasty with use of standard balloons

Drug-coated balloons

EXPERIMENTAL

Angioplasty with use of drug-coated balloons

Device: Drug-coated balloons

Drug-coated balloons and laser

EXPERIMENTAL

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

Device: Drug-coated balloonsDevice: Excimer Laser

Interventions

Drug-coated balloonsDEVICE
Also known as: In.Pact (Medtronic)
Drug-coated balloonsDrug-coated balloons and laser
Excimer LaserDEVICE
Also known as: SPECTRANETICS
Drug-coated balloons and laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient of age \> 18 years
  • Patient with previously peripheral implanted stent(s) located in or extending to the popliteal artery
  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Clinique Rhône Durance

Avignon, 84000, France

RECRUITING

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

RECRUITING

University Hospital of Bordeaux - Hospital Pellegrin

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, 21079, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69000, France

RECRUITING

Hôpital Timone Adultes

Marseille, 130005, France

WITHDRAWN

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

RECRUITING

Polyclinique Les Fleurs

Ollioules, 83190, France

RECRUITING

Hôpital Européen Georges Pompidou - AP-HP de Paris

Paris, 75015, France

RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

WITHDRAWN

Clinique de L'Europe

Rouen, 76100, France

RECRUITING

Centre Hospitalier Universitaire de St Etienne

Saint-Etienne, 42055, France

RECRUITING

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, 67091, France

RECRUITING

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

MeSH Terms

Interventions

Lasers, Excimer

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • 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

Central Study Contacts

Eric DUCASSE, MD, PhD

CONTACT

+335 56 79 55 25eric.ducasse@chu-bordeaux.fr

Olivier PERIOT

CONTACT

+335 57 82 04 59olivier.periot@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 6, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

FR(15)