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Angioplasty, BalloonPhase 3INTACTNCT02599389

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

A Phase 3 study testing Drug-coated balloons and Excimer Laser in people with Angioplasty, Balloon, run by University Hospital, Bordeaux at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angioplasty, Balloon
What is being tested?
Drug-coated balloons and Excimer Laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
13 sitesFrance
Study dates
Dec 2015to May 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Clinique Rhône Durance

    Avignon, 84000

  • Centre Hospitalier Universitaire de Besançon

    Besançon, 25030

  • University Hospital of Bordeaux - Hospital Pellegrin

    Bordeaux, 33000

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63000

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079

  • Hospices Civils de Lyon

    Lyon, 69000

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Polyclinique Les Fleurs

    Ollioules, 83190

  • Hôpital Européen Georges Pompidou - AP-HP de Paris

    Paris, 75015

  • Clinique de L'Europe

    Rouen, 76100

  • Centre Hospitalier Universitaire de St Etienne

    Saint-Etienne, 42055

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg, 67091

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

About this study

Official title: 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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug-coated balloonsDevice

    Also called In.Pact (Medtronic)

  • Excimer LaserDevice

    Also called SPECTRANETICS

Study groups in NCT02599389
Study groupRoleWhat they receive
Standard balloonNo interventionAngioplasty with use of standard balloons
Drug-coated balloonsExperimentalAngioplasty with use of drug-coated balloons
Receives: Device: Drug-coated balloons
Drug-coated balloons and laserExperimentalAngioplasty with use of drug-coated balloons in association with Excimer Laser
Receives: Device: Drug-coated balloons; Device: Excimer Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incremental cost per Qaly gained at 18 months

    Measured: 18 months after angioplasty

  2. Incremental cost per avoided stenosis relapse at 18 months

    Measured: 18 months after angioplasty

Secondary outcomes (9)

  1. 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.

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

  2. A major adverse event

    Absence of major event during follow-up as death, lower limb amputation or lack of required revascularization.

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

  3. Improvement in the walking procedure

    Improvement in the walking procedure performing by Strandness test

    Measured: Before and 12 months after angioplasty

  4. 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.

    Measured: 6 months, 12 months and 18 months after angioplasty

  5. Systolic blood pressure Index

    Index :ratio of brachial pressure and compressible leg artery pressure

    Measured: 6 months, 12 months and 18 months after angioplasty

  6. new treatment for the treated lesion

    Measured: 6 months, 12 months and 18 months after angioplasty

  7. revascularization, with restenosis of the treated lesion

    Measured: 6 months, 12 months and 18 months after angioplasty

  8. recurrence of clinical symptoms

    Measured: 6 months, 12 months and 18 months after angioplasty

  9. Blood ultrasonic doppler velocimetry

    Measured: 6 months, 12 months and 18 months after angioplasty

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionMay 2020
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02599389
Sponsor's protocol ID
CHUBX 2014/40
Other IDs
2015-A00924-45
Acronym
INTACT
Status last verified
Nov 2019
First submitted
5 Nov 2015
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38659343

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug-coated balloons and Excimer Laser in people with Angioplasty, Balloon, run by University Hospital, Bordeaux at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental cost per Qaly gained at 18 months (time frame: 18 months after angioplasty). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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