Status:
UNKNOWN
FrActional Flow Reserve Guided Drug Coated Balloon Only Strategy in De Novo coronarY Lesions (FADDY)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Ningbo No. 1 Hospital
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Drug-eluting stent (DES) has been the primary choice for in suit coronary lesions treatment. In comparison to bare-metal stent (BMS), it evidently decreases the rate of restenosis. However, in recent ...
Eligibility Criteria
Inclusion
- Clinical Criteria:
- Patients with age \>= 18 years old
- Patients with coronary artery disease is confirmed by angiography
- Patients with angina (CCS class II-IV) or documented ischemia evidence with ECG or ECT
- Patients agree to sign the informed consent
- Angiographic Criteria:
- In suit coronary lesions
- Reference diameters of target vessels by visual estimation from 2.5 mm to 3.5 mm and \< 28 mm in length
- Lesion diameter stenosis \>= 70% by visual estimation or \>= 50% with objective ischemia evidence (exercise stress testing, ECT or FFR\< 0.8)
Exclusion
- Clinical Criteria:
- Patients with STEMI \<= 1 week
- Patients with LVEF \< 30%
- Patients with bleeding diathesis or known anticoagulation dysfunction
- Patients with medical history regarding of intracranial tumor, aneurysm, arteriovenous malformation or cerebral apoplexy; stroke or TIA within 6 months; gastrointestinal hemorrhage within 2 months; major surgery within 6 weeks; recent or known platelet \< 100,000/mm3 or hemoglobin \< 10 g/dL
- Patients with planed selective operation probably leading to stopping using ADP receptor antagonists in advance
- Patients with life expectancy is less than 1 year because of combined comorbidity of other system
- Angiographic Criteria:
- Acute thrombotic lesions
- Left main coronary artery lesions
- Severe intima tear lesions
- Coronary artery bypass grafts lesions
- In-stent restenosis
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03452904
Start Date
January 1 2017
End Date
September 1 2018
Last Update
March 23 2018
Active Locations (1)
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1
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009