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OCT directs the application of drug-coated balloons to contrast drug-eluting stents in the treatment of STEMI patients: a prospective, multicenter, randomized controlled study

OCT directs the application of drug-coated balloons to contrast drug-eluting stents in the treatment of STEMI patients: a prospective, multicenter, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041946
Enrollment
Unknown
Registered
2021-01-10
Start date
2021-12-04
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

St-segment elevation myocardial infarction

Interventions

DCB group:Target lesions in DCB group were pretreated according to OCT classification
DES group:The DES group is pretreated in accordance with the current guidelines.

Sponsors

Tangdu Hospital of Air Force Millitary Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and = 0.1mv (> for 30 minutes, V2 and V3 >= 0.2mv) or newly developed left bundle branch block (LBBB); 3. Elevation of cardiac injury markers (troponin, CK-MB) beyond the 99th percentile of laboratory reference upper limit. 4. Target lesion length < 30mm;The vessel diameter of target lesion is between 2.5mm and 4.0mm. 5. No serious complications (no b-type or higher interlayer, no slow blood flow or reflow, and no residual stenosis < 30%) were found after preconditioning (thrombosis suction, balloon predilation, etc.); 6. Able to understand the purpose of the test, willing to participate in and sign the informed consent, willing to perform invasive imaging Patients were followed up.

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability; 2. Bifurcation lesions and bridge vascular lesions with left main or three-vessel lesions and branching vessel diameter >= 2.5mm; 3. Distorted or calcified target vessels; 4. Lesions that cannot be treated with PTCA or other interventional techniques; 5. After pre-dilation of the target lesion, residual stenosis >= 30% or TIMI blood flow < grade 3, and/or c-type or c-type or above interlayer appeared; 6. Subjects with severe congestive heart failure or NYHA LEVEL IV heart failure; 7. Women who are pregnant or breastfeeding; 8. Those who plan to undergo surgery within 6 months after surgery; 9. Subjects with a life expectancy of less than 1 year or with factors that make clinical follow-up difficult; 10. Existing or existing patients with severe liver and kidney dysfunction (liver failure, cirrhosis, portal hypertension, active hepatitis); 11. Heart transplant subjects; 12. Aneurysms, arteriovenous malformations and aortic dissection; 13. The researcher judged that the patient had poor compliance and could not complete the study as required; 14. Patients with definite diagnosis of tumor; 15. Patients who are participating in other clinical trials (except for other subjects of this project) but have not reached the time limit of the primary study endpoint; 16. Subjects deemed unfit for inclusion by the researcher for other reasons.

Design outcomes

Primary

MeasureTime frame
Target failure rate (TLF), including death, including cardiac death, target myocardial infarction, and clinically symptom-driven target revascularization (CD-TLR);

Secondary

MeasureTime frame
The incidence of MACE at 12 months after surgery was defined as cardiac death, clinically driven target vessel myocardial infarction, and clinically driven target lesion revascularization.;TLR;OCT associated clinical endpoints (TBD);

Countries

China

Contacts

Public ContactLi Yan

Tangdu Hospital of Air Force Millitary Medical University

307712565@qq.com+86 13892890227

Outcome results

None listed

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