Coronary Calcific LesionsCARDIACNCT07515703
Plaque Modification and Drug Coated Balloons for Treatment of de Novo Calcific Coronary Lesions
An observational study of Coronary Calcific Lesions and Plaque Modification Technique, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The optimal management of severely calcified coronary artery disease remains challenging, particularly in the context of drug-coated balloon (DCB) angioplasty. This study aimed to evaluate the feasibility, safety, and mid-term clinical outcomes of a DCB-only strategy following coronary modification systems (CMS) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Calcific Lesions, Plaque Modification Technique, Drug Coated Balloon
- What is being tested?
- IVL3003
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 1 Mar 2026
- 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: all patients with severe calcific coronary lesions treated with plaque modification and solo DCB PCI
Who may be able to join
- Inclusion criteria comprised patients aged ≥18 years with stable or unstable coronary artery disease (chronic coronary syndrome [CCS] or acute coronary syndrome [ACS]) eligible for percutaneous coronary intervention (PCI).
Who cannot join
- Angiographic exclusion criteria included in-stent restenosis (ISR), lesions treated with a hybrid approach (DCB plus drug-eluting stent [DES]), residual stenosis >30%, or ≥ type C dissection after lesion preparation. Clinical exclusion criteria were hemodynamic instability and life expectancy <1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CARDIAC Trial: Coronary AtheRectomy and Drug Coated Ballon Intervention in All-comer Calcific Lesions
The optimal management of severely calcified coronary artery disease remains challenging, particularly in the context of drug-coated balloon (DCB) angioplasty. This study aimed to evaluate the feasibility, safety, and mid-term clinical outcomes of a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease.
- Being tested
- IVL3003
- Keywords
- dcb, rotablation, ivl, orbital atherectomy
- Medical subject headings
- Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVL3003Device
Also called DRUG COATED BALLOON
management of severely calcified coronary artery with a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial im)
The primary endpoints were: procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial infarction), and ischemia-driven target lesion revascularization (TLR), assessed at the last available follow-up.
Secondary endpoints included major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization, as well as any revascularization.
Measured: 2019-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Mar 2019
- Primary completion1 Jun 2025
- Study completion1 Mar 2026
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 Calcific LesionsStudies 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
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Benedetto, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515703
- Sponsor's protocol ID
- CMS and DCB for CAC
- Acronym
- CARDIAC
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: is a multicenter registry where the choice of treatment is related with operators preference
Publications
Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. EuroIntervention. 2025 Apr 24;21(19):e1116-36. doi: 10.4244/EIJ-E-25-00021. Online ahead of print.
PubMed 40272160
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIAC Trial: Coronary AtheRectomy and Drug Coated Ballon Intervention in All-comer Calcific Lesions
- ClinicalTrials.gov ID
- NCT07515703
- Acronym / sponsor ID
- CARDIAC / CMS and DCB for CAC
- Keywords
- dcb, rotablation, ivl, orbital atherectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 7 Apr 2026 (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.
The optimal management of severely calcified coronary artery disease remains challenging, particularly in the context of drug-coated balloon (DCB) angioplasty. This study aimed to evaluate the feasibility, safety, and mid-term clinical outcomes of a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with severe calcific coronary lesions treated with plaque modification and solo DCB PCI
Key inclusion criteria (1 listed)
- Inclusion criteria comprised patients aged ≥18 years with stable or unstable coronary artery disease (chronic coronary syndrome [CCS] or acute coronary syndrome [ACS]) eligible for percutaneous coronary intervention (PCI).
Key exclusion criteria (1 listed)
- Angiographic exclusion criteria included in-stent restenosis (ISR), lesions treated with a hybrid approach (DCB plus drug-eluting stent [DES]), residual stenosis >30%, or ≥ type C dissection after lesion preparation. Clinical exclusion criteria were hemodynamic instability and life expectancy <1 year.
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 |
|---|---|---|
| IVL3003Also: DRUG COATED BALLOONmanagement of severely calcified coronary artery with a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease. | Device | – |
Primary outcome
procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial im)
Time frame: 2019-2026
The primary endpoints were: procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial infarction), and ischemia-driven target lesion revascularization (TLR), assessed at the last available follow-up. Secondary endpoints included major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization, as well as any revascularization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 40272160Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. EuroIntervention. 2025 Apr 24;21(19):e1116-36. doi: 10.4244/EIJ-E-25-00021. Online ahead of print.
- Individual participant dataSharing planned: Undecided. is a multicenter registry where the choice of treatment is related with operators preference
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Calcific Lesions and Plaque Modification Technique, run by University of Rome Tor Vergata at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial im) (time frame: 2019-2026). 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 NCT07515703, 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 7 Apr 2026.