The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Pati… (NCT03624205) | Clinical Trial Compass
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The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients
520 participantsStarted 2015-04-24
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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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 relat…
What they're measuring
1
Target Lesion Failure in 12 months after operation
Timeframe: 1 year
Trial details
NCT IDNCT03624205
SponsorB. Braun Medical International Trading Company Ltd.