chronic total occlusion of coronary artery
Conditions
Interventions
DCB group (Experimental group):CTO lesions were treated only with drug balloon dilation after predilation
DES group(control group):CTO lesions were treated only with DES implantation after predilation
Sponsors
The Affiliated Huaian NO.1 People‘s Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old <= age <= 80 years old. 2. Patients with coronary heart disease confirmed by coronary angiography or coronary CTA. 3. Clinical indications for CTO revascularization judged by physicians can refer to the following criteria: Prior imaging or CTA indicated that the patient had at least one complete epicardial vessel occlusion combined with at least one ischemic indication: (1) The occluded vessels are located in the near middle part of the anterior descending branch or the near middle part of the right coronary artery, which has a large blood supply range, and the patients still have cardiac seizure after drug treatment; (2) There are signs of severe myocardial ischemia, regardless of whether there is abnormal ventricular wall movement; (3) There were no signs of severe myocardial ischemia, but the exercise stress test indicated that the ischemia range was greater than 10% of the left ventricular weight. 4. The reference diameter of target lesion vessels was 2.25-3.5mm. 5. If there are non-target lesions that require concurrent treatment, non-target lesions should be treated before target lesions and no serious complications after treatment.
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria: 1. Diagnosed as acute ST elevation myocardial infarction by the investigators; 2. Severe heart failure (HYHA Grade IV) or left ventricular ejection fraction 30%) (3) Coronary dissection (NHLBI standard Grade C or above) (4) Coronary artery perforation 2. Bifurcation lesions with lateral branches requiring stent implantation; 3. Left main disease; 4. Intrastent restenosis; 5. Graft disease of people underwent CABG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| in-segment target lesion late lumen lose(LLL); | — |
Secondary
| Measure | Time frame |
|---|---|
| device-oriented composite,DoCE;target lesion restenosis rate(RR);SAQ(Seattle Angina Questionnaire) score-7;Cardiovascular related hospitalization;Technical success;Procedural success;patient-oriented composite,PoCE;in-segment diameter and area stenosis of target lesions;bleeding; | — |
Countries
China
Contacts
Public ContactZhang Xiwen
The Affiliated Huaian NO.1 People‘s Hospital of Nanjing Medical University
Outcome results
None listed