Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions

NCT05016726 | Unknown DMC FDA Device

• 1 other identifier: 001
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Residual stenosis < 30%

  intra-procedural

• Serious angiographic complications

  intra-procedural

• MACE at 6 and 12 months

  at 6 and 12 months

• Target lesion failure (TLF)

  at 30 days, 6 and 12 months.

• Other clinical secondary outcomes

  at 30 days, 6 months nd 12 months.

Interventions

Intravascular Lithotripsy DEVICE

Intravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent.

Also known as: Rotational Atherectomy, Orbital Atherectomy

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age;
• Native coronary artery disease suitable for PCI;
• 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.
• Patient or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures;
• The target vessel reference diameter must be ≥2.5 mm.
• 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.
• 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;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• SS Annunziata Hospital, Savigliano: lead

Related Publications (1)

• Cerrato E, Pavani M, Zecchino S, Leoncini M, Zanda G, Abdirashid M, Cordone S, Nicolino A, Franze A, Bernardi A, Lio V, Boi A, Marengo G, Presutti DG, Vadala P, Secco GG, Conrotto F, Vergallo R, Menozzi A, Berchialla P, Tomassini F, Patti G, Musumeci G, Chinaglia A, Varbella F. Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries: Multicenter, Prospective ROLLING STONE Study. JACC Cardiovasc Interv. 2026 Jan 24:S1936-8798(25)03190-5. doi: 10.1016/j.jcin.2025.11.033. Online ahead of print.

  PMID: 41609534 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

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

MARCO PAVANI, MD

CONTACT

+39 3281598831; marcopavani@alice.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 23, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2024
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share