Patients with coronary artery calcified lesions
Conditions
Interventions
ADMIRE Strategy Group:IVUS-guided Aggressive Debulking with Minimal-stent Intervention Strategy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, either sex. 2. Scheduled for percutaneous coronary intervention (PCI) because of symptomatic coronary artery disease—stable angina pectoris, unstable angina pectoris, or non-ST-segment elevation myocardial infarction (NSTEMI). 3. The patient (or legally authorized representative) must fully understand the study and voluntarily sign the written Informed Consent Form (ICF) before any study-related procedure. 4. Target lesion(s) located in a native coronary artery main vessel or major side branch with a reference vessel diameter (RVD) >= 2.0 mm. 5. The target lesion must be de novo (i.e., not in-stent restenosis). 6. The target lesion must exhibit severe calcification documented by intravascular ultrasound as a calcium arc >= 180°. 7. The operator intends to treat the target lesion with the ADMIRE strategy defined in this study. The core workflow is: (1) Imaging-guided throughout: IVUS planned for every step of the procedure. (2) Aggressive lesion preparation: rotational atherectomy (RA) with a burr-to-artery ratio (BAR) >= 0.6 as the primary initial debulking step, followed by optimized balloon angioplasty as needed. (3) Intended final therapy: after the above preparation, the operator expects to finish with drug-coated balloon (DCB) alone or a hybrid "DCB + minimal stenting" approach.
Exclusion criteria
Exclusion criteria: 1. Acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI (culprit vessel). 2. Target lesion located in a saphenous vein graft (SVG) or an arterial graft. 3. Target lesion is a chronic total occlusion (CTO) (unless successfully recanalized and meets all other inclusion criteria). 4. Target lesion is an in-stent restenosis (ISR). 5. Known severe allergy to study-related drugs or device components, including but not limited to: contrast media, antiplatelet agents (aspirin, P2Y12 inhibitors), heparin, bivalirudin, DCB coating drugs (e.g., paclitaxel, sirolimus and their derivatives), DES metallic materials (e.g., cobalt-chromium, platinum-chromium alloys) or polymer coatings. 6. Presence of severe bleeding diathesis or active bleeding, or a history of life-threatening bleeding within the recent past (e.g., within 6 months). 7. Severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m², and the patient is not on chronic stable hemodialysis. 8. Severe hepatic impairment (e.g., Child-Pugh class C). 9. Life expectancy <12 months (due to non-cardiac reasons). 10. Patient is pregnant, lactating, or planning to become pregnant during the study period. 11. Patient is currently participating in another interventional clinical trial that might interfere with the results of this study. 12. After reviewing baseline imaging, the operator determines that the ADMIRE strategy is unsuitable for the patient/lesion or plans to use a non-ADMIRE treatment approach. 13. Inability to complete the follow-up requirements of the study for any reason (e.g., psychiatric condition, poor compliance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month Target Lesion Revascularization (TLR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Procedure-Related Complications;Technical Success Rate;Acute Gain;In-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate;Procedural Success Rate;Final IVUS Assessment Results;Post-Lesion Preparation IVUS Assessment Results;12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate;Rate of Major Bleeding Events at 12 Months; | — |
Countries
China
Contacts
Public ContactLiang Pan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed