Clinical trial NCT03624205: The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients
Official title: To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary In Sentrestenosis
Lead sponsor: B. Braun Medical International Trading Company Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with coronary In sentrestenosis

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


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
* 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;

Primary outcomes:
measure: Target Lesion Failure in 12 months after operation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: