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

NCT05394649 | Unknown

• 1 other identifier: RBHP 2021 HONTON
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 17

Brief 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). 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.

Conditions

Intravascular Lithotripsy; Rotational Atherectomy; OFDI

Outcome Measures

Primary Outcomes (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).

  Day 1

Secondary Outcomes (1)

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

  Day 30

Study Arms (2)

Intravascular lithotripsy arm

EXPERIMENTAL

Preparation of calcified lesions by intravascular lithotripsy before stenting

Device: Intravascular Lithotripsy

Rotational Atherectomy arm

ACTIVE COMPARATOR

Preparation of calcified lesions by rotational atherectomy before stenting

Device: Rotational Atherectomy

Interventions

Intravascular Lithotripsy DEVICE

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.

Intravascular lithotripsy arm

Rotational Atherectomy DEVICE

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.

Rotational Atherectomy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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")

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Clinique Pasteur Toulouse: collaborator

Study Sites (17)

Groupe SAnté Victor Pauchet

Amiens, France

NOT YET RECRUITING

Clinique Rhône Durance

Avignon, France

NOT YET RECRUITING

CHU Jean Minjoz

Besançon, France

NOT YET RECRUITING

CHU Bordeaux

Bordeaux, France

NOT YET RECRUITING

Clinique Saint Augustin

Bordeaux, France

NOT YET RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

GH Mutualiste Grenoble

Grenoble, France

NOT YET RECRUITING

Institut Cardiologique Paris sud

Massy, France

NOT YET RECRUITING

Clinique du Millénaire

Montpellier, France

NOT YET RECRUITING

Clinique Pasteur

Nancy, France

NOT YET RECRUITING

Nouvelle Clinique Nantaise

Nantes, France

NOT YET RECRUITING

CHU Nîmes

Nîmes, France

NOT YET RECRUITING

Hôpital Européen de Paris GVM la Roseraie

Paris, France

NOT YET RECRUITING

Institut Mutualiste Montsouris

Paris, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, France

NOT YET RECRUITING

Clinique Saint Hilaire

Rouen, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arms: * Intravascular lithotripsy arm * Rotational Atherectomy arm

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: August 4, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)