- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624205
The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients
August 8, 2018 updated by: B. Braun Medical International Trading Company Ltd.
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.
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
520
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patient with coronary In sentrestenosis
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Lesion Failure in 12 months after operation
Time Frame: 1 year
|
To measure Target Lesion Failure in 12 months by using angiography
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2015
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Actual)
August 10, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAG-O-H-1414
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on paclitaxel-releasing coronary balloon (SeQuent® Please)
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Ralf Degenhardt, PhDB. Braun Melsungen AGCompletedCoronary Heart DiseasesIndia
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ZhuHai Cardionovum Medical Device Co., Ltd.R&G Pharma Studies Co.,Ltd.Completed
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University of UlmB. Braun Melsungen AGCompletedCoronary Artery Disease | Chronic Total Occlusion | Native Coronary ArteryGermany
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Gachon University Gil Medical CenterChonbuk National University Hospital; Chonnam National University Hospital; Ulsan... and other collaboratorsUnknownCoronary Artery DiseaseKorea, Republic of
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Shanghai MicroPort Medical (Group) Co., Ltd.Recruiting
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B. Braun Medical Industries Sdn. Bhd.Seoul National University Hospital; Ulsan University Hospital; European Cardiovascular... and other collaboratorsRecruitingMyocardial Ischemia | Coronary Artery Disease | Acute Coronary Syndrome | Coronary Stenosis | De Novo StenosisMalaysia, Korea, Republic of, Singapore, Taiwan
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B. Braun Medical International Trading Company...UnknownSmall Vessel DiseaseChina
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B. Braun Medical International Trading Company...CompletedCoronary Instent RestenosisChina