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Intravascular Lithotripsy; Rotational Atherectomy; OFDIICARENCT05394649

Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

A study testing Intravascular Lithotripsy and Rotational Atherectomy in people with Intravascular Lithotripsy; Rotational Atherectomy; OFDI, run by University Hospital, Clermont-Ferrand at 17 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intravascular Lithotripsy and Rotational Atherectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
17 sitesFrance
Study dates
4 Aug 2022to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 ≥ 18 years old
  • Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI)
  • For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of the lab (URL) normal within 12 hours prior to the procedure
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with:
  • Stenosis of ≥70% and <100%
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  • or Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80
  • The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • The lesion length must not exceed 40 mm
  • The target vessel must have TIMI flow 3 at baseline
  • Evidence of calcification at the lesion with a B or C Mintz classification site:
  • B: Moderate calcification: radiopacities are noted only during the cardiac cycle before contrast injection C: severe calcification: radiopacities are seen without cardiac motion, also before contrast injection, usually affecting both sides of the arterial lumen.
  • Ability to pass a 0.014" guidewire across the lesion
  • Ability to cross target lesion with a 2 mm balloon
  • Patient insured under the French healthcare system ("Régime National Assurance Maladie")
  • Lesions in non-target vessels requiring PCI may be treated either:
  • a. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
  • b. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation >normal; or
  • c. >30 days after the study procedure d. Could be treated in the same time of the diagnosis coronarography with respect of the delay for the index procedure of the protocol as described above
  • Patient able to assess and understand the risks and benefits, to accept and participate in the study (by signing an informed consent form and knowledgeable of the information letter).
  • Patient accepting the appropriate follow-up as per study definition

Who cannot join

  • Patient age < 18 years
  • The subject is pregnant or nursing
  • Patient refusing to participate in the study or unable to give informed consent (Guardianship, curatorship or judicial safeguard)
  • Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  • The protected subject according to the current legislation (articles L.1121-5 to L.1121-8 of the French Code of Public Health).
  • The subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device), unless it is authorized by the concomitant study protocol.
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  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months
  • The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
  • The subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 time the local laboratory's upper normal limit
  • New York Heart Association (NYHA) class III or IV heart failure
  • History of a stroke or Transient Ischemic Attack (TIA) within 6 months, or any prior intracranial hemorrhage
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  • Uncontrolled diabetes defined as an HbA1c >10%
  • Subjects in cardiogenic shock
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • Subjects with a life expectancy of less than 1 year
  • Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA, or PFO occlusion…) within 30 days prior to the index procedure
  • Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion...)
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • High SYNTAX Score (≥33) if assessed as a standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
  • Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • Evidence of aneurysm in target vessel within 10 mm of the target Lesion
  • Unprotected left main
  • Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • Angiographic evidence of dissection in the target vessel at baseline or after guidewire passage
  • Ejection fraction less than 30 % evaluated in TTE, angiography or MRI
  • Patient suffering of lymphoma, leukemia and other malignancies
  • Patient suffering of liver disease

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Groupe SAnté Victor Pauchet

    Amiens

  • Clinique Rhône Durance

    Avignon

  • CHU Jean Minjoz

    Besançon

  • CHU Bordeaux

    Bordeaux

  • Clinique Saint Augustin

    Bordeaux

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • GH Mutualiste Grenoble

    Grenoble

  • Institut Cardiologique Paris sud

    Massy

  • Clinique du Millénaire

    Montpellier

  • Clinique Pasteur

    Nancy

  • Nouvelle Clinique Nantaise

    Nantes

  • CHU Nîmes

    Nîmes

  • Hôpital Européen de Paris GVM la Roseraie

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • CHU Poitiers

    Poitiers

  • Clinique Saint Hilaire

    Rouen

  • Clinique Pasteur

    Toulouse

Other trials in France

About this study

The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

Read the detailed description

Calcified coronary lesions will increase in daily percutaneous coronary intervention regarding the significant epidemiological increase of factors leading to coronary calcifications, such as hypertension, aging, and diabetes. Furthermore, calcified lesions are underdiagnosed in angiography as shown by intra-coronary imaging studies (either by OCT or IVUS), which reported that significant calcium deposits might be present in 76-83% of lesions. Calcified lesions are associated with a larger amount of periprocedural complications, as well as a poorer clinical prognosis. Standard techniques to prep the calcified plaque, such as rotational or orbital atherectomy, still have low penetration and are associated with an increase in periprocedural complications without clear clinical evidence of efficacy. More recently, there has been a growing interest in intravascular lithotripsy (IVL), which appears as an appealing option with recently published data with evidence for a safe procedure but without robust data on efficacy (sample size population, debatable effectiveness endpoint…). Although the European Society of Cardiology highlights in the latest myocardial revascularization guidelines the need for lesion preparation before stent implantation on short- and long-term clinical outcomes, no specific recommendation has been given on the use of the dedicated devices to prepare the plaque, including atherectomy, which is left to the operator assessment.

Being tested
Intravascular Lithotripsy, Rotational Atherectomy

What participants receive

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

  • Intravascular LithotripsyDevice

    A new device has been designed by Shockwave Medical Inc. for the treatment of calcified vascular lesions to support stent delivery: the "C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system". The system is based on lithotripsy to induce microfractures in the calcified plaque before low-pressure balloon dilation. The C2 Shockwave Medical® coronary lithotripsy (IVL) system consists of an IVL Catheter with two lithotripsy emitters enclosed within an integrated balloon, an IVL Generator, and an IVL Connector Cable.

  • Rotational AtherectomyDevice

    Rotational Atherectomy is a technique of calcic coronary plaque preparation based on the debulking of superficial calcium by a high-speed burr in order to improve vessel compliance and immediate vessel lumen gain before stenting.

Study groups in NCT05394649
Study groupRoleWhat they receive
Intravascular lithotripsy armExperimentalPreparation of calcified lesions by intravascular lithotripsy before stenting
Receives: Device: Intravascular Lithotripsy
Rotational Atherectomy armActive comparatorPreparation of calcified lesions by rotational atherectomy before stenting
Receives: Device: Rotational Atherectomy

What is being measured

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

  1. acute Minimal Stent Area (MSA) defined as in-stent minimal cross-sectional area as assessed by OFDI without In-Hospital MACE (Major Adverse Cardiac Event).

    To assess the efficacy of IVL in a randomized fashion comparing to Rotational atherectomy by final Minimal Stent Area (MSA) measurements with Optical Frequency Domain Imaging (OFDI).

    Measured: Day 1

Secondary outcomes (1)

  1. MACE: Cardiac Death, all Myocardial Infarction and Target Lesion Revascularization

    To assess safety of IVL in a randomized fashion comparing to Rotational atherectomy by checking the apparition of Major Adverse Cardiac Event (MACE) after 30 days: Cardiac death, all Myocardial Infarction (MI) and Target Lesion Revascularization (TLR)

    Measured: Day 30

Timeline

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

  1. First posted27 May 2022
  2. Study start4 Aug 2022
  3. Primary completion31 May 2024
  4. Study completion31 Dec 2027 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel arms: * Intravascular lithotripsy arm * Rotational Atherectomy arm
Masking
None (open label)
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394649
Sponsor's protocol ID
RBHP 2021 HONTON
Acronym
ICARE
Status last verified
Aug 2026
First submitted
24 May 2022
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Honton B, Motreff P, Mallet JS, Hovasse T, Godin M, Malcles G, Brunet J, Meneveau N, Deharo P, Lattuca B, Bressollette E, Angioi M, Benamer H, Gerbaud E, Pereira B, Cesario V, Poinas A, Laperche C, Sauguet A, Souteyrand G, Amabile N, Combaret N. Intravascular lithotripsy in comparison to rotational atherectomy for calcified lesions: the ICARE OFDI randomised trial. EuroIntervention. 2026 Aug 3;22(15):e808-e819. doi: 10.4244/EIJ-D-26-00426.

    PubMed 42200665

Questions about this trial

What is this clinical trial studying?

A study testing Intravascular Lithotripsy and Rotational Atherectomy in people with Intravascular Lithotripsy; Rotational Atherectomy; OFDI, run by University Hospital, Clermont-Ferrand at 17 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 21 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

acute Minimal Stent Area (MSA) defined as in-stent minimal cross-sectional area as assessed by OFDI without In-Hospital MACE (Major Adverse Cardiac Event). (time frame: Day 1). 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 NCT05394649, 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 30 Oct 2026.

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