ST Segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
Drug Coated Autoperfusion Balloon Dilatation Catheter, Percutaneous Coronary Intervention, VUS-OCT Multimodal Imaging, De novo lesion
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).
Interventions
DEVICEDrug 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.
DEVICEConventional 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
LanZhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss at 9 months after index PCI | 9±2 months | Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Bleeding Academic Research Consortium type 3 and 5 bleeding complications |
| Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation | index PCI | Based on the results of coronary angiography after DCB implantation |
| 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 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. |
| Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging. | 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. |
| Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation. | index PCI | Incidence of intolerable worsening chest pain, hemodynamic instability, ST-segment changes, and severe arrhythmias during DCB expansion and duration of DCB expansion. |
| The incidence of bailout stenting following DCB implantation | 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. |
Countries
China
Contacts
Primary ContactJing Zhao, Dr
Backup ContactYurun Su, Dr
Outcome results
None listed