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Revascularization with paclitaxel-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarction-a randomized controlled trial

Revascularization with paclitaxel-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarction-a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083632
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-04-30
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction

Interventions

Test group:Drug eluting balloon implantation

Sponsors

The first hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Acute myocardial infarction meeting PPCI criteria: ·>20 min chest pain, ST segment elevation of at least two adjacent leads by 1 mm, a new left bundle branch block or positive posterior wall myocardial infarction ·Reperfusion is expected to be feasible within 12 hours of onset Acute myocardial infarction with thrombolytic therapy within 6 hours and remedial PCI within 24 hours Meet the inclusion criteria of infarct related arteries of PPCI ·Primary coronary artery disease ·Reference vessel diameter = 2.5 mm and = 4 mm ·No severe calcification ·Diameter stenosis after thrombus aspiration and pre dilation shall not exceed 50% (visual inspection)

Exclusion criteria

Exclusion criteria: Age 75 years ·History of myocardial infarction ·Known contraindications / bivalirudin, fondaparinux sodium, heparin, aspirin, prasugrel and / or ticagrel ·Participate in another clinical study to interfere with this protocol ·Uncertain neurological outcomes, such as resuscitation ·Intubation / ventilation ·Cardiac shock before randomization ·Known intracranial diseases (mass, aneurysm, arteriovenous malformation, hemorrhagic CVA, ischemic CVA / TIA < 6 months ago, including or ischemic cerebrovascular disease (permanent neurological defect) ·Gastrointestinal / urinary tract bleeding within 2 months before inclusion ·Refuse blood transfusion ·Major surgery is planned within 6 weeks ·Stent implantation < 1 month before inclusion ·Life expectancy less than 12 months

Design outcomes

Primary

MeasureTime frame
Quantitative Flow Ratio;

Secondary

MeasureTime frame
Major adverse cardiac events;

Countries

CHINA

Contacts

Public ContactMing bai

The first hospital of Lanzhou University

baim@lzu.edu.cn+86 138 9322 0909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026