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

Lanzhou University

Status: Not yet enrolling

Conditions: ST Segment Elevation Myocardial Infarction (STEMI)

Treatments: Device: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）; Device: Conventional Drug coated balloon (DCB)

Study type: Interventional

Funder types: Other

Identifiers

NCT06794801

LLYY2024PJ171

Details and patient eligibility

About

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).

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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;
11. Cardiogenic shock prior to randomization;
12. Known intracranial disease (tumors, aneurysms, arteriovenous malformations, hemorrhagic CVA, ischemic CVA/TIA within the last 6 months, including permanent neurological deficits from ischemic cerebrovascular disease) ;
13. Refusal of blood transfusion;
14. Planned major surgery within 6 weeks;
15. Stent implantation < 1 month prior to enrollment;
16. Life expectancy of less than 12 months;
17. Participation in another clinical trial that interferes with this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

134 participants in 2 patient groups

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）

Experimental group

Description:

3 μg/mm² paclitaxel-coated drug-coated autoperfusion balloon dilatation catheter (DCAB). The DCAB features two radiopaque marker rings at the balloon shoulders for intravascular imaging and positioning, self-perfusion holes on the catheter shaft, and an additional radiopaque marker ring proximal to the perfusion holes to indicate their location. The catheter shaft is hydrophilically coated to facilitate blood flow through the perfusion holes when the guidewire is retracted. Preclinical studies show this design allows 15%-20% of arterial blood to reach the distal coronary artery.

Treatment:

Device: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）

Conventional Drug coated ballon（DCB）

Active Comparator group

Description:

Bingo® PTCA Drug Delivery System: drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2.

Treatment:

Device: Conventional Drug coated balloon (DCB)