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Efficacy, Safety and cost-effectiveness of anti-proliferative treatment of coronary arteries with catheter-based delivery of fluid paclitaxel after bare-metal stenting to reduce restenosis in high-risk patients: A multicenter randomized controlled study

Efficacy, Safety and cost-effectiveness of anti-proliferative treatment of coronary arteries with catheter-based delivery of fluid paclitaxel after bare-metal stenting to reduce restenosis in high-risk patients: A multicenter randomized controlled study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002484
Enrollment
Unknown
Registered
2012-09-04
Start date
2012-09-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Cardiovascular Disease

Interventions

2:anti-proliferative treatment

Sponsors

Nil
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 80, males or females; 2. Clinical evidence of ischemia or a positive function test; 3. Willingness and ability to adhere to the study conditions; 4. Written informed consent after patient information; 5. Opted to self-pay or receive government subsidy for BMS; 6. Coronary artery stenosis >=50% that is accessible to balloon angioplasty; 7. Presence of one or more risk factors for restenosis: (i) diabetes mellitus; (ii) target vessel diameter =20mm; (iv) bifurcation lesion; (v) instent restenosis; (vi) chronic total occlusion.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction; 2. Contraindications or allergy paclitaxel; 3. Pregnancy, breastfeeding or possibility of pregnancy during the study period; 4. Coexisting conditions that limited life expectancy to =4mm in diameter; 10. Target vessel contains visible thrombus.

Design outcomes

Primary

MeasureTime frame
Late Lumen Loss;—

Countries

Malaysia

Contacts

Public ContactProfessor Bryan YAN Ping Yen
bryan_yan@cuhk.edu.hk+852 26323846

Outcome results

None listed

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