Skip to content

Application of double-guided wire balloon cutting technique combined with drug-coated balloon (DCB) in primary coronary lesions (De Novo)

Application of double-guided wire balloon cutting technique combined with drug-coated balloon (DCB) in primary coronary lesions (De Novo)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023706
Enrollment
Unknown
Registered
2019-06-08
Start date
2019-07-05
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Coronary heart disease

Interventions

Case series:Double guidewire balloon cutting+DCB

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged = 18 years, male and female; 2. Diagnosis of acute coronary syndrome (unstable angina or acute non-ST-segment elevation myocardial infarction); 3. Coronary angiography showed untreated primary coronary artery lesions (De Novo), lesion diameter stenosis >75%, reference diameter =2.5mm and =3.5mm, lesion length =10mm and =25mm; 4. Subjects volunteered to join the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. pregnancy, or lactating women; 2. Acute ST-segment elevation myocardial infarction; 3. Cardiogenic shock, severe cardiac insufficiency or left ventricular dysfunction (left ventricular ejection fraction 221 µmol/L (2.5 mg/d1) or eGFR < 30 ml/min/1.73 m^2 (calculated according to the MDRD formula); 8. Severe liver damage (hild-Pugh grade C), biliary cirrhosis and cholestasis; AST, ALT greater than 3 times the upper limit of normal, or previous cirrhosis, portal hypertension, esophageal varices, etc.; 9. Life expectancy <12 months; 10. Unwilling or unable to provide informed consent; 11. The criteria for coronary angiography exclusion are as follows: (1) Chronic total occlusion disease; (2) left main lesion; (3) Moderate to severe tortuosity or severe calcification; (4) Severe coronary dissection (NHLBI type C-E) after expansion; (5) Coronary artery bypass graft lesions.

Design outcomes

Primary

MeasureTime frame
Late lumen loss;

Countries

China

Contacts

Public ContactBo Zhang

The First Affiliated Hospital of Dalian Medical University

dalianzhangbo@yahoo.com+86 18098875726

Outcome results

None listed

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