Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions (ROLLING-STONE)

Intravascular Lithotripsy and/or Mechanical Debulking Multicenter Registry for the Treatment of Complex Calcified Coronary Arteries: the ROLLING-STONE.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Device: Intravascular Lithotripsy

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

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: MARCO PAVANI, MD; Phone Number: +39 3281598831; Email: marcopavani@alice.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure.	The primary safety endpoint was freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. Definition of MACE: Composite of; cardiac death;; myocardial infarction (MI): CK-MB level >3 times the upper limit of lab normal (ULN) value with or without new pathologic Q waves at discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI); target vessel revascularization: revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.	within 30 days of index procedure
Number of Participants With Procedural Success	The primary effectiveness endpoint was procedural success defined as stent delivery with a residual stenosis <20% (Image Core Laboratory-Assessed) and without intra-procedural MACE.	within 30 days of index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual stenosis < 30%	Stent delivery with ≤30% residual stenosis and without serious angiographic complications.	intra-procedural
Serious angiographic complications	Severe dissection (Type D to F), perforation, abrupt closure, persistent slow flow or persistent no reflow, pericardial effusion, access-site complications (in-hospital).	intra-procedural
MACE at 6 and 12 months	Cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR).	at 6 and 12 months
Target lesion failure (TLF)	Cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods at 30 days, 6 and 12 months.	at 30 days, 6 and 12 months.
Other clinical secondary outcomes	All death, cardiac death, MI, target vessel MI (TV-MI), ischemia-driven TVR (ID-TVR), ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)	at 30 days, 6 months nd 12 months.
Intraprocedural secondary outcome	1.Minimal Lumen Diameter pre-stenting and post-stenting (mm at QCA evaluation)	intra-procedure
Intraprocedural secondary outcome	Minimal Lumen Area (mm2) pre-stenting and post stenting (IVUS/OCT)	intra-procedure
Intraprocedural secondary outcome	QFR value at the end of the procedure	intra-procedure

Collaborators and Investigators

• Sponsor: SS Annunziata Hospital, Savigliano

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes