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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-01-27

No results posted yet for this study

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).

Conditions

  • ST Segment Elevation Myocardial Infarction (STEMI)

Interventions

DEVICE

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）

In the experimental arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successfully prepared lesions will be treated with a drug-coated autoperfusion balloon dilatation catheter (DCAB). Successful lesion preparation is defined as post-pretreatment residual stenosis ≤ 30%, no type C dissections, intravascular imaging confirming no significant residual plaque burden at the dissection site, no transverse expansion \> 60°, no longitudinal expansion \> 2 mm, no dissection involving the media or adventitia, and no location at the stent distal end. There should be no hematoma and no significant thrombus (TIMI thrombus burden grade ≤ 2). If the angiographic and intravascular imaging results after DCAB treatment are unsatisfactory, an emergency drug-eluting stent (DES) will be implanted.

DEVICE

Conventional Drug coated balloon (DCB)

In the control arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successful lesion preparation (residual stenosis ≤ 30%, no type C dissections, no significant residual plaque burden, no dissection involving the media or adventitia, no transverse expansion \> 60°, no longitudinal expansion \> 2 mm, no location at the stent distal end, no hematoma, TIMI thrombus burden grade ≤ 2) will be treated with a conventional DCB coated with 3 μg/mm2 paclitaxel. If angiographic and intravascular imaging results are unsatisfactory, a bailout DES will be implanted.

Sponsors & Collaborators

  • LanZhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794801 on ClinicalTrials.gov