Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intravascular Lithotripsy; Rotational Atherectomy; OFDI
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 178
- Locations
- 16
- Primary Endpoint
- 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).
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
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).
Secondary Outcomes
- MACE: Cardiac Death, all Myocardial Infarction and Target Lesion Revascularization(Day 30)