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Evaluation of the efficacy and safety for drug-eluting balloon in patients with coronary artery diseases.

Evaluation of the efficacy and safety for drug-eluting balloon in patients with coronary artery diseases

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INC-17014054
Enrollment
Unknown
Registered
2017-12-20
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Coronary artery disease

Interventions

Drug stenting group:Drug stenting
Drug balloon group:Drug balloon

Sponsors

Shanghai sxth people‘s hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in and sign informed consent; 2. 18 years of age or older; 3. All coronary heart disease patients treated with PCI; 4. The diameter of the target vessel was observed in all patients with 2.5mm-4.0 mm; 5. The degree of visual coronary artery stenosis was more than 80%; 6. If the degree of coronary stenosis is less than 80%, there must be an objective evidence of myocardial ischemia or imaging evidence to indicate the rupture or instability of the plaque.

Exclusion criteria

Exclusion criteria: 1. Patients with bleeding tendency, active gastrointestinal ulcer history, cerebral hemorrhage or subarachnoid hemorrhage history, half a year history of stroke, antiplatelet agents and anticoagulant treatment contraindications can not be treated with anticoagulant therapy; 2. Aspirin, clopidogrel, or ticlopidine, heparin, contrast agent, paclitaxel, rapamycin, and metal allergy; 3. The life expectancy of the patients was less than 12 months, and the age was more than 80 years old; 4. Unprotected left main stem lesions and their bifurcations by contrast; 5. After ordinary balloon treatment, there was severe coronary artery dissection (type C and C type dissection), or residual stenosis after dilatation > 50%, or distended distal flow TIMI < 3; 6. Participants who participated in clinical trials of other drugs or medical devices before admission were not limited to the main end point of the study; 7. The researchers decided that the patient's compliance was poor and was unable to complete the study as required.

Design outcomes

Primary

MeasureTime frame
electrocardiogram;Echocardiography;Myocardial enzyme;Coagulation index;ProBNP;

Contacts

Public ContactMeng Wei

Shanghai sxth people's hospital

mjyww2009@126.com+86 18930174762

Outcome results

None listed

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