Coronary in-stent restenosis
Conditions
Interventions
test group:Shanghai Xinzhi Medical Technology Co., Ltd. drug eluting balloon catheter
Control group:B.Braun Melsungen AG SeQuent Please Paclitaxel Releases Coronary Balloon Catheter
Sponsors
Xijing Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18-80 years old, male or non-pregnant women; 2.Patients with asymptomatic myocardial ischemia, stable or unstable angina, or old myocardial infarction; 3.Patients who are eligible for PTCA, PCI or CABG treatment; 4.Patients who can understand the purpose of the trial, voluntarily participate in and sign a written informed consent form, and can be followed up. Related to target lesions: 5.Restenosis after metal stent, Mehran type I, II or III; 6.Reference vessel diameter 2.0mm-4.0mm, lesion length = 30mm (visual inspection); 7.In-stent restenosis diameter stenosis rate = 70% or = 50% (visual) with evidence of ischemia; 8.It is expected that no more than 2 drug balloons will be used for in-stent restenosis lesions in each subject requiring treatment; 9.Other primary lesions requiring restenosis and restenosis lesions = 10mm.
Exclusion criteria
Exclusion criteria: Related to patients: 1.A woman who is pregnant or breast-feeding, or who has a birth plan in the next year; 2.A history of cerebral hemorrhage, active peptic ulcer, or gastrointestinal bleeding within 3 months; 3.Patients with acute ST-segment elevation myocardial infarction within one week prior to intervention; 4.Patients with severe heart failure (NYHA class IV); 5.Preoperative renal dysfunction patients: serum creatinine > 200umol / L; 6.Patients with bleeding tendency, antiplatelet agents and anticoagulant treatment contraindications, unable to perform anticoagulant therapy; 7.Patients with a history of allergy to paclitaxel and contrast agents; 8.Patients with a life expectancy of less than 12 months; 9.Patients with contraindications to drug balloon products; 10.Participating in any other clinical trial; 11.The investigator judges patients who are poorly compliant and cannot complete the study as required; Related to target lesions: 12.Left main stenosis lesions; 13.Bridge vessel restenosis lesions; 14.In addition to restenosis lesions, there are >2 primary lesions requiring treatment; 15.The main stent is restenosis in the bifurcation lesion, and the distance from the side branch opening with diameter = 2.5 mm is = 5 mm; 16.Restenosis lesions that cannot be successfully pre-expanded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss in the 9-month target lesion segment; | — |
Countries
China
Contacts
Public ContactYong He
Outcome results
None listed