Loading clinical trials...

Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study

An Open-Label, Prospective, Single-Center, Randomized Controlled Trial Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study

NCT06794801•LanZhou University

View on ClinicalTrials.gov

Summary

Trial Goals: 1. Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation Myocardial Infarction (STEMI). 2. Evaluation of Hybrid IVUS-OCT System for Intraoperative Evaluation of DCAB or Conventional DCB Treatment Safety and Effectiveness for De Novo Lesions During Emergency Percutaneous Coronary Intervention (PCI) in Patients with STEMI. The primary outcome is late lumen loss (LLL) assessed at 9 months following emergency PCI, measured using quantitative coronary angiography (QCA).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Acute ST-Elevation Myocardial Infarction Meeting PPCI Criteria: 1) Chest pain lasting more than 20 minutes, with ST-segment elevation of at least 1 mm in two or more adjacent leads, new left bundle branch block, or evidence of posterior wall myocardial infarction; 2) Onset of symptoms within 12 hours.
•2. Patients Who Have Received Thrombolytic Therapy Within 6 Hours of Symptom Onset and Are Eligible for Rescue PCI Within 24 Hours;
•3. Infarct-Related Artery Selection Imaging and Pre-Treatment Criteria Meeting PPCI Standards: 1) De novo lesions. 2) Reference vessel diameter between 2.5 mm and 4 mm. 3) Successful pre-treatment of target lesions: post-pre-treatment residual stenosis of the culprit vessel ≤ 30%, with no type C dissections (or intravascular imaging indicating significant residual plaque burden at the site of dissection, with transverse expansion \> 60°, longitudinal expansion \> 2 mm, dissection involving the media or adventitia, and located at the distal end of the stent), no hematoma, and no significant thrombus (TIMI thrombus burden grade ≤ 2);
•4. Sufficient compliance with the study protocol, agreement to undertake follow-up, and coronary angiography at 9 months;
•5. Voluntary Participation in This Study, Including Signing a Written Informed Consent with Understanding of All Risks and Benefits Described in the Informed Consent Document.

Exclusion Criteria

•1. Age \< 18 years and \> 75 years;
•2. History of prior myocardial infarction;
•3. Allergy to contrast agent/inability to tolerate contrast;
•4. Known contraindications / inability to tolerate bivalirudin, fondaparinux, heparin, aspirin, clopidogrel, and/or ticagrelor;
•5. Complex coronary lesions: left main lesions, lesions at the ostia of the left anterior descending or circumflex arteries, lesion length \> 30 mm, severe calcification, severe tortuosity or angulation, bifurcation lesions requiring the implantation of more than two drug-coated balloons (DCBs) or drug-eluting stents;
•6. In-stent restenosis or in-stent thrombus lesions;
•7. Planned simultaneous intervention on non-target lesions;
•8. Active bleeding or recent history of bleeding;
•9. Uncertain neurological outcomes, such as resuscitation;
•10. Intubation / ventilation;
+7 more criteria

Locations (1)

LanZhou University

Lanzhou, Gansu, China

Key Dates

Start Date

January 1, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2030

Last Updated

January 27, 2025

Enrollment

134

ESTIMATED participants

Conditions

ST Segment Elevation Myocardial Infarction (STEMI)

Interventions

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）

DEVICE

Conventional Drug coated balloon (DCB)

DEVICE

Contacts

Jing Zhao, Dr

CONTACT

+8618919062327 jzhao14@fudan.edu.cn

Yurun Su, Dr

CONTACT

+8615682845605 15682845605@163.com

Early Beta Blocker Administration in STEMI Patients With SCAI B Status

NCT06967194

ST Segment Elevation Myocardial Infarction (STEMI)Cardiogenic Shock Post Myocardial Infarction

View study

COMPLETEDPHASE3

A Multicenter Trial to Assess the MIcrovascular Integrity and Left Ventricular Function Recovery After Clopidogrel or TicagrelOr Administration, in Patients With STEMI Treated With Thrombolysis - The 'MIRTOS' Study

NCT02429271

Myocardial InfarctionST Segment Elevation Myocardial Infarction (STEMI)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions