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Clinical Trial of BA9 for intracoronary stent restenosis

A prospective, multicenter, noninferiority, randomized controlled trial comparing the safety and efficacy of Biolimus-released coronary balloon catheters with paclitaxel released coronary balloon catheters (SeQuent Please Neo) in the treatment of in-stent restenosis of coronary arteries

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041438
Enrollment
Unknown
Registered
2020-12-26
Start date
2020-12-30
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Coronary heart disease (CHD)

Interventions

Experimental group:Biolimus was released into the coronary artery for balloon catheter treatment
The control group:Taxol release SeQuent Please Neo) treatment

Sponsors

The First Medical Center of the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients older than 18 and younger than 80 years old; 2. Patients with stable angina pectoris, acute coronary syndrome, old myocardial infarction or confirmed silent myocardial ischemia; 3. Patients without contraindications of coronary revascularization (PCI or CABG); 4. Patients who agreed to receive clinical follow-up at discharge, 1 month, 6 months, 9 months, 1 year, 2 years and 3 years after operation, and angiographic follow-up at 9 months after operation; 5. The subjects who can understand the purpose of the study have enough compliance with the study protocol. And willing to sign the informed consent, and accept the risks and benefits described in the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with any myocardial infarction within 1 week, or patients whose myocardial enzyme CK or CK-MB has not returned to normal although myocardial infarction has occurred for more than 1 week; 2. Patients with severe congestive heart failure (NYHA IV) or severe valvular heart disease; 3. Female patients who are planning or are pregnant (or breastfeeding); 4. Patients with severe renal failure with creatinine > 2.0 mg/dL (177 mol/L); 5. Left ventricular ejection fraction < 30%; 6. Coagulation disorders, platelet count < 100 x 10^9/ L; 7. Patients with cardiogenic shock; 8. Patients with concomitant diseases requiring cytoinhibitor or radiotherapy; 9. Patients who are known to be allergic to aspirin, clopidogrel, Gracilis, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel, or Ticagrelor; 10. Patients with bleeding constitution or a history of cerebral hemorrhage, active digestive ulcer, or gastrointestinal bleeding in the past 6 months will be restricted or prohibited to use anticoagulant therapy or anticoagulant drugs; 11. Patients with a life expectancy of less than 1 year or with underlying factors of difficult clinical follow-up; 12. Patients who are participating in any other clinical trial; 13. For other reasons, the researchers considered the patients unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Segmental late lumen loss of target lesions 9 months after surgery;

Countries

China

Contacts

Public ContactChen Yundai

PLA General Hospital

Cyundai@medmail.com.cn+86 10-55499009

Outcome results

None listed

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