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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Sirolimus-coated Coronary Balloon Dilatation Catheter |
|
| Control Group | Active Comparator | Drug Eluting Balloon Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus-coated Coronary Balloon Dilatation Catheter | Device | During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Late luminal loss (LLL) | Late luminal loss (LLL) within the target lesion segment at 9 months postoperatively | 9 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | Successful delivery and dilatation of the drug-coating balloon catheter across lesion, and target lesion residual stenosis≤30% (visual inspection) without additional interventional treatment. | Immediately after PTCA |
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Inclusion Criteria:
Exclusion Criteria:
Patients who had a myocardial infarction within 7 days before enrollment (2) Patients with cardiogenic shock (3) Patients with renal insufficiency (eGFR < 30 ml/min) or vital organ failure (4) Patients with known allergy or intolerance to contrast media or to rapamycin, paclitaxel and/or their analogs (5) Patients with hematologic disorders, or contraindications to anticoagulant/antiplatelet agents, or intolerance to aspirin or clopidogrel (6) Patients with severe valvular heart disease or who have undergone heart transplantation (7) Patients who are not suitable for coronary artery bypass graft surgery (CABG) (8) Patients with congestive heart failure or NYHA class IV (9) Patients who have had a stroke within 6 months prior to enrollment, or have a history of gastrointestinal bleeding or active gastric ulcers, or who have been determined by the investigator to have a bleeding constitution (10) Patients with a life expectancy of less than 1 year (11) Pregnant or lactating females (12) Patients who are participating in clinical trials of other drugs or medical devices (13) Patients who, in the opinion of the investigator, are not suitable for enrollment for other reasons.
(14) Totally occluded (TIMI grade 0) lesions (15) Presence of coronary artery spasm without significant stenosis (16) Unprotected left main stem lesions (17) Patients with a bifurcation lesion (branch diameter ≥2.00 mm) as the target lesion (18) Patients with target lesions that are severely tortuous (preventing smooth catheter passage) or severely calcified (19) Patients with secondary stenosis caused by pre-dilatation of the target lesion (20) Patients with a well-defined thrombus in the target vessel
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug-coated Coronary Balloon Dilatation Catheter | Device | During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Drug-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |