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

January 22, 2025 updated by: BAI MING, LanZhou University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • LanZhou University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yurun Su, M.S.
        • Sub-Investigator:
          • Jing Zhao, M.D.
        • Sub-Investigator:
          • Bo Zhang, B.S.
        • Sub-Investigator:
          • Youqi Zhu, B.S.
        • Sub-Investigator:
          • Xinghu Zhou, M.D.
        • Sub-Investigator:
          • Cunrui Zhao, M.S.
        • Sub-Investigator:
          • Peng Lei, M.D.
        • Sub-Investigator:
          • Erkun Xing, B.S.
        • Sub-Investigator:
          • Jinglei Niu, M.S.
        • Sub-Investigator:
          • Junqian Wang, M.S.
        • Sub-Investigator:
          • Wei Hu, M.S.
        • Sub-Investigator:
          • Zhijie Yan, M.S.
        • Sub-Investigator:
          • Xuan Qiao, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）
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.
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.
Active Comparator: Conventional Drug coated ballon（DCB）
Bingo® PTCA Drug Delivery System: drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2.
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.
Other Names:
  • Bingo® PTCA Drug Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late lumen loss at 9 months after index PCI
Time Frame: 9±2 months
Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention.
9±2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of patient-oriented composite endpoint (PoCE)
Time Frame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of patient-oriented composite endpoint (PoCE) and individual components of PoCE: defined as a composite of all-cause death, Target vessel failure, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.
3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications
Time Frame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Bleeding Academic Research Consortium type 3 and 5 bleeding complications
3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation
Time Frame: index PCI
Based on the results of coronary angiography after DCB implantation
index PCI
The incidence of bailout stenting following DCB implantation
Time Frame: index PCI
The following criteria are used to define it: TIMI flow ≤ Grade 2; residual stenosis > 30%; Type C (or intravascular imaging demonstrating significant residual plaque burden at the dissection site, lateral extension > 60°, longitudinal extension > 2 mm, dissection involving the media or adventitia); and higher dissection.
index PCI
Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.
Time Frame: index PCI
Change in minimum lumen area and lumen area loss (in mm2), as assessed by IVUS-OCT multimodal imaging, compared with pre-procedure baseline following coronary artery drug-coated balloon angioplasty.
index PCI
Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation.
Time Frame: index PCI
Incidence of intolerable worsening chest pain, hemodynamic instability, ST-segment changes, and severe arrhythmias during DCB expansion and duration of DCB expansion.
index PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LanZhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLYY2024PJ171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data is available and can be requested, subject to approval, if a reasonable clinical research analysis plan is provided to the corresponding author.

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Submit a detailed research analysis plan to the corresponding author and apply through our email.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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