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 | Not Yet Recruiting

• 1 other identifier: LLYY2024PJ171
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Trial Goals:

1. 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. 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.

Conditions

ST Segment Elevation Myocardial Infarction (STEMI)

Keywords

Drug Coated Autoperfusion Balloon Dilatation Catheter; Percutaneous Coronary Intervention; VUS-OCT Multimodal Imaging; De novo lesion

Outcome Measures

Primary Outcomes (1)

• Late lumen loss at 9 months after index PCI

  Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention.

  9±2 months

Secondary Outcomes (6)

• Incidence of patient-oriented composite endpoint (PoCE)

  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

  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

  index PCI

• The incidence of bailout stenting following DCB implantation

  index PCI

• Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.

  index PCI

Study Arms (2)

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）

EXPERIMENTAL

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）

Conventional Drug coated ballon（DCB）

ACTIVE COMPARATOR

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)

Interventions

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB） DEVICE

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.

Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）

Conventional Drug coated balloon (DCB) DEVICE

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.

Also known as: Bingo® PTCA Drug Delivery System

Conventional Drug coated ballon（DCB）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients Who Have Received Thrombolytic Therapy Within 6 Hours of Symptom Onset and Are Eligible for Rescue PCI Within 24 Hours;
• 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);
• Sufficient compliance with the study protocol, agreement to undertake follow-up, and coronary angiography at 9 months;
• Voluntary Participation in This Study, Including Signing a Written Informed Consent with Understanding of All Risks and Benefits Described in the Informed Consent Document.

You may not qualify if:

• Age \< 18 years and \> 75 years;
• History of prior myocardial infarction;
• Allergy to contrast agent/inability to tolerate contrast;
• Known contraindications / inability to tolerate bivalirudin, fondaparinux, heparin, aspirin, clopidogrel, and/or ticagrelor;
• 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;
• In-stent restenosis or in-stent thrombus lesions;
• Planned simultaneous intervention on non-target lesions;
• Active bleeding or recent history of bleeding;
• Uncertain neurological outcomes, such as resuscitation;
• Intubation / ventilation;
• Cardiogenic shock prior to randomization;
• 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) ;
• Refusal of blood transfusion;
• Planned major surgery within 6 weeks;
• Stent implantation \< 1 month prior to enrollment;

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

LanZhou University

Lanzhou, Gansu, 730000, China

Location

Related Publications (19)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Jing Zhao, Dr

CONTACT

+8618919062327; jzhao14@fudan.edu.cn

Yurun Su, Dr

CONTACT

+8615682845605; 15682845605@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Using a core laboratory, an impartial third-party evaluation will be carried out for this study to objectively assess each participant's intravascular imaging and coronary angiography results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months
• Access Criteria: Submit a detailed research analysis plan to the corresponding author and apply through our email.

Locations

CN (1)