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Drug-coated balloon and drug-eluting stents in the treatment of severe coronary calcification under the guidance of OCT:a multi-center, randomized controlled study

Drug-coated balloon and drug-eluting stents in the treatment of severe coronary calcification under the guidance of OCT:a multi-center, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061611
Enrollment
Unknown
Registered
2022-06-29
Start date
2022-06-15
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

coronary atherosclerotic heart disease

Interventions

DES group:Drug-eluting stents

Sponsors

Fuwai Central China Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40 - 75 years; 2. Patients clinically diagnosed as coronary atherosclerotic heart disease, coronary angiography showed that PCI was needed, OCT confirmed that lesion is coronary artery intimal calcification, OCT score >= 2, and the lesion after pre-treatment is suitable for drug-eluting stent and drug-coated balloon. 3. For patients with diabetes and hypertension, blood sugar and blood pressure were up to standard before operation; 4. Patients and their families signed the informed consent, and were willing to cooperate with the follow-up until 12 months after operation.

Exclusion criteria

Exclusion criteria: 1. NYHA > III, or left ventricular ejection fraction < 30%; 2. In-stent restenosis after coronary artery bypass grafting or PCI; 3. Patients with muscular bridge, severe angular lesions, extensive thrombosis in the diseased vessels, and severe valvular heart disease requiring surgical treatment; 4. Patients who can't tolerate dual antiplatelet therapy, antiplatelet therapy and/or anticoagulation therapy contraindicated; 5. Patients with severe organ dysfunction, autoimmune diseases, malignant tumors, or expected survival time <= 3 years; 6. Pregnant women, patients with iodine contrast agent, paclitaxel, rapamycin allergy or contraindication of interventional therapy.

Design outcomes

Primary

MeasureTime frame
Late lumen loss;

Secondary

MeasureTime frame
Target Lesion Revascularizition;major adverse cardiac events;

Countries

China

Contacts

Public ContactYang Honghui

Fuwai Central China Cardiovascular Hospital

18703710099@163.com+86 18703710099

Outcome results

None listed

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