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
NCT ID: NCT06794801
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
134 participants
INTERVENTIONAL
2025-01-31
2030-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Conventional Drug coated ballon（DCB）
Bingo® PTCA Drug Delivery System: drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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LanZhou University
OTHER
Responsible Party
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BAI MING
MD
Locations
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LanZhou University
Lanzhou, Gansu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.
Suryapranata H, van 't Hof AW, Hoorntje JC, de Boer MJ, Zijlstra F. Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction. Circulation. 1998 Jun 30;97(25):2502-5. doi: 10.1161/01.cir.97.25.2502.
Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 Aug 13;106(7):798-803. doi: 10.1161/01.cir.0000025585.63486.59.
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
Brott BC, Anayiotos AS, Chapman GD, Anderson PG, Hillegass WB. Severe, diffuse coronary artery spasm after drug-eluting stent placement. J Invasive Cardiol. 2006 Dec;18(12):584-92.
Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.
Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.
Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.
Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.
Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman JP, Kiemeneij F, Patterson MS, Slagboom T, van der Schaaf RJ. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014 Sep;10(5):584-90. doi: 10.4244/EIJV10I5A101.
Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.
Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvanne M, Suttorp MJ, Violini R, Schomig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.
Kim HS, Lee JH, Lee SW, Kim YH, Park JH, Choi SW, Jeong JO, Seong IW, Rhee KS, Ko JK, Jo SH, Choi YJ. Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial. Int J Cardiol. 2011 Mar 3;147(2):253-7. doi: 10.1016/j.ijcard.2009.09.466. Epub 2009 Sep 26.
Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.
Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.
Hao X, Huang D, Wang Z, Zhang J, Liu H, Lu Y. Correction to: Study on the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. J Cardiothorac Surg. 2021 Sep 3;16(1):247. doi: 10.1186/s13019-021-01629-1. No abstract available.
Other Identifiers
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LLYY2024PJ171
Identifier Type: -
Identifier Source: org_study_id
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