Coronary Artery DiseaseROLLING-STONENCT05016726
Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions
An observational study of Coronary Artery Disease and Myocardial Infarction, run by SS Annunziata Hospital, Savigliano.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Intravascular Lithotripsy
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Oct 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- General Inclusion Criteria:
- ≥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;
- Angiographic Inclusion Criteria:
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Intravascular Lithotripsy
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular LithotripsyDevice
Also called Rotational Atherectomy, Orbital Atherectomy
Intravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 30 days of index procedure
Secondary outcomes (8)
Residual stenosis < 30%
Stent delivery with ≤30% residual stenosis and without serious angiographic complications.
Measured: 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).
Measured: intra-procedural
MACE at 6 and 12 months
Cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR).
Measured: 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.
Measured: 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)
Measured: at 30 days, 6 months nd 12 months.
Intraprocedural secondary outcome
1.Minimal Lumen Diameter pre-stenting and post-stenting (mm at QCA evaluation)
Measured: intra-procedure
Intraprocedural secondary outcome
Minimal Lumen Area (mm2) pre-stenting and post stenting (IVUS/OCT)
Measured: intra-procedure
Intraprocedural secondary outcome
QFR value at the end of the procedure
Measured: intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- SS Annunziata Hospital, Savigliano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Pavani, SS Annunziata Hospital, Savigliano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016726
- Sponsor's protocol ID
- 001
- Acronym
- ROLLING-STONE
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 Mar 9;19(5):571-582. doi: 10.1016/j.jcin.2025.11.033. Epub 2026 Jan 29.
PubMed 41609534
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Lithotripsy and/or Mechanical Debulking Multicenter Registry for the Treatment of Complex Calcified Coronary Arteries: the ROLLING-STONE.
- ClinicalTrials.gov ID
- NCT05016726
- Acronym / sponsor ID
- ROLLING-STONE / 001
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- SS Annunziata Hospital, SaviglianoUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- ≥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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular LithotripsyAlso: Rotational Atherectomy, Orbital AtherectomyIntravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent. | Device | – |
Primary outcome
Number of Participants Who Experienced Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure.
Time frame: within 30 days of 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.
Number of Participants With Procedural Success
Time frame: within 30 days of index procedure
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.
8 secondary outcomes
Residual stenosis < 30%
Time frame: intra-procedural
Serious angiographic complications
Time frame: intra-procedural
MACE at 6 and 12 months
Time frame: at 6 and 12 months
Target lesion failure (TLF)
Time frame: at 30 days, 6 and 12 months.
Other clinical secondary outcomes
Time frame: at 30 days, 6 months nd 12 months.
Intraprocedural secondary outcome
Time frame: intra-procedure
Intraprocedural secondary outcome
Time frame: intra-procedure
Intraprocedural secondary outcome
Time frame: intra-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 41609534Cerrato 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 Mar 9;19(5):571-582. doi: 10.1016/j.jcin.2025.11.033. Epub 2026 Jan 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by SS Annunziata Hospital, Savigliano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARCO PAVANI, MD (+39 3281598831, marcopavani@alice.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. (time frame: within 30 days of index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05016726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.