Skip to content

A prospective, randomized controlled trial comparing the safety and efficacy of paclitaxel-coated balloons with drug-eluting stents in patients with acute coronary syndrome

A prospective, randomized controlled trial comparing the safety and efficacy of paclitaxel-coated balloons with drug-eluting stents in patients with acute coronary syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024420
Enrollment
Unknown
Registered
2019-07-10
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Acute coronary syndrome

Interventions

Drug coated balloon group:Drug-coated balloon dilatation
Drug eluting stent group:Stent implantation

Sponsors

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 Related to the Subject (1) Unstable angina; (2) Non-ST-segment elevation myocardial infarction; (3) ST-segment elevation myocardial infarction: patients with chest pain greater than 20 minutes and at least two consecutive leads ST segment at least 1 mm elevation; or new left bundle branch block or posterior myocardial infarction (confirmed by electrocardiogram or echocardiography), reperfusion is expected to be within 12 hours after the appearance of the main complaint of chest pain; (4) Subjects must agree to undergo a 9-month angiographic follow-up and 30-day, 6-month, 9-month, and 12-month clinical follow-up; 2 Associated with lesions: (1) New lesions of the in situ coronary artery; (2) Reference vessel diameter >= 2.5mm and <= 4mm; (3) No serious calcifications and distortions; (4) Residual diameter stenosis after thrombus aspiration and pre-expansion <= 50%, and no significant thrombus residue (visual); (5) Each target lesion can only be treated with a SeQuent Please drug balloon or drug stent.

Exclusion criteria

Exclusion criteria: 1 Related to the subject; (1) Those aged 75 years; (2) History of previous myocardial infarction; (3) It is known that diarrhea, heparin, aspirin, clopidogrel and/or ticagrelor are intolerant or allergic; (4) Are participating in additional clinical studies and have an impact on the study; (5) Cardiac shock before randomization; (6) Known intracranial disease (lumps, aneurysms, cerebral arteriovenous malformations, hemorrhagic cerebrovascular accidents (CVA), ischemic CVA / transient ischemic attack within 6 months, or with permanent neurological deficits Ischemic CVA); (7) A history of digestive tract or urinary tract bleeding within 2 months; (8) Planned major surgery within 6 weeks; (9) A history of stent implantation in January; (10) Subjects with a life expectancy of no more than 1 year or who have difficulty in clinical follow-up; (11) Subjects with severe valvular heart disease; (12) Pregnant or lactating women; (13) Existing or have a history of severe liver failure; (14) Existing or have a history of severe renal failure (eGFR = 50% or the TIMI blood flow is <3, and/or the C-type or C-type interlayer is present.

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac events;Clinical symptom-driven target lesion revascularization;

Countries

China

Contacts

Public ContactZhanglu Li

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

alu511520@163.com+86 15858223977

Outcome results

None listed

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