Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT03624205
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;
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03624205
Study Brief:
Protocol Section:
NCT03624205