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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVL3003 | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2019-2026 |
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Inclusion Criteria:
Exclusion Criteria:
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all patients with severe calcific coronary lesions treated with plaque modification and solo DCB PCI
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniela Benedetto | Rome | Rome | 00133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40272160 | Background | 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. |
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is a multicenter registry where the choice of treatment is related with operators preference
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| ID | Term |
|---|---|
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| D000077765 |
| Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |