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

NCT ID: NCT03624205

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 520 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-24
• Study Completion Date: 2022-03-01

Brief Summary

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

Conditions

Coronary In Sentrestenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

paclitaxel-releasing coronary balloon (SeQuent® Please)

SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial

Intervention Type: DEVICE

Eligibility Criteria

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
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Medical International Trading Company Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AAG-O-H-1414

Identifier Type: -

Identifier Source: org_study_id