The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients

B. Braun

Status: Unknown

Conditions: Coronary In Sentrestenosis

Treatments: Device: paclitaxel-releasing coronary balloon (SeQuent® Please)

Study type: Observational

Funder types: Industry

Identifiers

NCT03624205

AAG-O-H-1414

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients

Enrollment: 520 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Criteria related to subjects

• At the age of 18-80, Both male and female;
• Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery
• After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection
• Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions
• The target lesion length and target vessel diameter should be consistent with the instructions of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）

Exclusion criteria

Criteria related to subjects

• Women with pregnancy or lactation
• Patient with cardiac shock
• Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory
• Patients with severe valvular heart disease
• Patients with severe congestive heart failure or NYHA class IV heart failure;
• Patients who have received heart transplant;
• Patients with life expectancy more than 60 months, or those who is difficulties in clinical follow-up.
• Patients who are currently involved in any other clinical trial;
• Patients that the investigators think that those are not suitable Criteria related to lesions
• Chronic total occlusion
• Lesion that cannot be treated with PTCA or other interventional techniques;
• The vessel diameter < 2.25 mm
• Left main disease needed to be treated Exclusion criteria related to concomitant medication
• Patients who are intolerant to aspirin and/or clopidogrel or have a history of neutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiency and contraindicated for clopidogrel.
• Patients who are known to be intolerant or allergic to heparin, contrast agent, paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainless steel;