Skip to content

A prospective, multicenter, confirmatory clinical trial of rapamycin drug stent system

A prospective, multicenter, confirmatory clinical trial of rapamycin drug stent system

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092205
Enrollment
Unknown
Registered
2024-11-12
Start date
2019-08-13
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable or unstable angina, obsolescence Sexual myocardial infarction

Interventions

Experimental group:Interventional stent therapy
Control group:Interventional stent therapy

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Participants in this study must meet all of the following criteria: 1. Subjects aged 18-75, male or non-pregnant female; 2. Evidence of asymptomatic myocardial ischemia, stable or unstable angina pectoris, and obsolescence Subjects with sexual myocardial infarction; 3. Target lesions were those of primary and in-situ coronary artery stenosis, with the number of target lesions =2; 4. The maximum number of stents implanted in each target lesion is =2 stents of the same type; 5. Length of each target lesion =30mm, diameter of target vessel 2.5mm-4.0mm (visual method); 6. Target lesion diameter stenosis =70% (visual method); 7. Subjects with indications of percutaneous coronary intervention and coronary artery bypass grafting; 8. Left ventricular ejection fraction (LVEF) =40% or cardiac function grade =?; LVEF measured within 6 months before operation was effective for stable coronary heart disease subjects. 9. Can understand the purpose of the test, voluntarily participate in and sign the informed consent, and be willing to accept the angiography And clinical follow-up subjects.

Exclusion criteria

Exclusion criteria: If you have any of the following conditions, you will be excluded from participating in this clinical trial 1. Subjects with acute myocardial infarction within one month; 2. Subjects with chronic complete occlusive lesions (preoperative TIMI grade 0 blood flow), left main lesions that need to be treated, opening lesions, severe calcification lesions and twisting lesions, three-branch lesions, bifurcation lesions with branch vessel diameter =2.5mm, and bridge vessel lesions; 3. Subjects with intrastent restenosis; 4. Thrombotic lesions; History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within six months; Or have permanent neurological deficits or any known intracranial lesions (aneurysms, arteriovenous malformations, etc.); 5.1 Subjects who have had any brand of stent implanted in their coronary arteries within the past year; 6. Subjects with white blood cell count 2.0mg/dl); 8. Cardiogenic shock, acute infection, subjects with a high risk of bleeding or a history of coagulation disorders, or with a history of major gastrointestinal bleeding or ulcers within 6 months, and subjects with contraindications to antiplatelet preparations and anticoagulants that cannot be treated with antithrombotic therapy; 9. Subjects who are allergic to aspirin, clopidogrel, ticagrelor or ticlopidine, heparin, contrast agents, sirolimus, zotamolus, polymers, metals, or have allergy or contraindications to aspirin, clopidogrel or ticlopidine; 10. Subjects with a life expectancy of less than 1 year; 11. Participated in clinical trials of other drugs or medical devices before inclusion and did not meet the primary study endpoint The subject of; 12. Subjects whose compliance is judged by the researcher to be poor and unable to complete the test as required; 13. Subjects receiving heart transplants;

Design outcomes

Primary

MeasureTime frame
9 months (+30 days) of stent segmental late lumen loss. Note: In the segment refers to the bracket near and far within 5mm.;

Countries

China

Contacts

Public ContactLv Shuzheng

Beijing Anzhen Hospital, Capital Medical University

shuzheng023@163.com+86 139 1106 5536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026