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

NCT03624205 | Unknown DMC

• 1 other identifier: AAG-O-H-1414
• Study Type: observational
• Target: 520
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure in 12 months after operation

  To measure Target Lesion Failure in 12 months by using angiography

  1 year

Interventions

paclitaxel-releasing coronary balloon (SeQuent® Please) DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with coronary In sentrestenosis

You may qualify if:

• 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）

You may not qualify if:

• 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;

Sponsors & Collaborators

• B. Braun Medical International Trading Company Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: April 24, 2015
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 10, 2018

Record last verified: 2018-08