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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

Sponsor: LanZhou University

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2025-01

Completion Date

2030-12

Last Updated

2025-01-27

Healthy Volunteers

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.

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.

Locations (1)

LanZhou University

Lanzhou, Gansu, China