Clinical trial NCT06794801: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction (STEMI)
Keywords: Drug Coated Autoperfusion Balloon Dilatation Catheter
Percutaneous Coronary Intervention
VUS-OCT Multimodal Imaging
De novo lesion
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Late lumen loss at 9 months after index PCI
timeFrame: 9±2 months
Secondary outcomes:
measure: Incidence of patient-oriented composite endpoint (PoCE)
timeFrame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
measure: Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications
timeFrame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
measure: Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation
timeFrame: index PCI
measure: The incidence of bailout stenting following DCB implantation
timeFrame: index PCI
measure: Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.
timeFrame: index PCI
measure: Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation.
timeFrame: index PCI
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: LanZhou University
state: Gansu
Study officials:
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