Clinical trial NCT05016726: Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions
Official title: Intravascular Lithotripsy and/or Mechanical Debulking Multicenter Registry for the Treatment of Complex Calcified Coronary Arteries: the ROLLING-STONE.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: SS Annunziata Hospital, Savigliano
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with a novel diagnosis of complex severe calcified coronary artery confirmed by core-lab analysis of coronary angiograms or other intravascular imaging available

Brief summary: To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.

Detailed description: At present age, there are few real-world data published about the use of intravascular lithotripsy. Its safety and possible procedural complications remain unclear, and the effects of combination with other plaque-modification devices are unknown. Finally, there are few data about long-term outcomes in the real-life setting.

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with Stable CAD or Acute Coronary Syndromes, that are suitable for percutaneous coronary intervention (PCI). Approximately 400 subjects at 20 sites will be enrolled. Subjects will be followed through discharge, 30 days, 6 and 12 months

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria:

1. ≥18 years of age;
2. Native coronary artery disease suitable for PCI;
3. Patients with stable ischemic heart disease or unstable ischemic heart disease (Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-Elevation Myocardial Infarction), patients with concomitant cardiogenic shock.
4. Patient or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures;

Angiographic Inclusion Criteria:

1. The target vessel reference diameter must be ≥2.5 mm.
2. De novo coronary lesions or calcific in-stent restenosis or suboptimal stent expansion in a severely calcified coronary segment: Unprotected or Protected Left Main, LAD, LCfx, Ramus, RCA.
3. Angiographic stenosis \> 70% or stenosis \> 50% and \< 70% with FFR \< 0.80 or iFR \< 0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²;
4. Evidence of calcification at the lesion site: angiographic calcifications (Mintz el al Classification) are described as : None/mild, Moderate (radio-opacities noted only during cardiac cycle prior to contrast injection) severe calcification: radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.

Exclusion Criteria:

1. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint;
2. Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);
3. Patient has an allergy to imaging contrast media which cannot be adequately pre-medicated;
4. Patient has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics;

Primary outcomes:
measure: Number of Participants Who Experienced Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure.
timeFrame: within 30 days of index procedure
measure: Number of Participants With Procedural Success
timeFrame: within 30 days of index procedure
Secondary outcomes:
measure: Residual stenosis < 30%
timeFrame: intra-procedural
measure: Serious angiographic complications
timeFrame: intra-procedural
measure: MACE at 6 and 12 months
timeFrame: at 6 and 12 months
measure: Target lesion failure (TLF)
timeFrame: at 30 days, 6 and 12 months.
measure: Other clinical secondary outcomes
timeFrame: at 30 days, 6 months nd 12 months.
measure: Intraprocedural secondary outcome
timeFrame: intra-procedure
measure: Intraprocedural secondary outcome
timeFrame: intra-procedure
measure: Intraprocedural secondary outcome
timeFrame: intra-procedure
Other outcomes:
Locations:
Study officials:
References: