- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691675
DCB in de Novo Coronary Lesion
Prospective Clinical Research on Safety and Efficacy of Drug Coated Balloon in de Novo Coronary Lesion With Diameters Larger Than 2.75 mm Under OCT Guidance
Study Overview
Detailed Description
Stable or unstable angina patients who accept drug coated balloon dilatation therapy with diameter stenosis≥50%, reference diameter≥2.75mm will be enrolled. OCT examination should be carried out after radiography, predilation, Drug coated balloon dilatation and follow-up.
For target lesion, balloon should be used for predilation (the ratio of balloon diameter to vascular diameter being 0.8-1.0:1), and for good predilation effects, high pressure balloon, cutting balloon, dual-wire balloon and spines balloon can be adopted. OCT examination should be carry out after balloon satisfactory predilation. Satisfactory predilation radiography result is residual stenosis≤30%,TIMI 3 flow without major dissections (type C or higher) in NHLBI classification. OCT satisfactory result is residual stenosis≤30% without dissection, or with dissection but the dissection angle is ≤90°. Then carry out DCB balloon dilatation therapy. The ratio of balloon diameter to vascular diameter is 0.8-1.0:1, and both ends of DCB exceed the preprocessing area of lesion for 2-3mm, thus avoiding the occurrence of geographical mismatch. Dilation pressure is 8-10atm, lasting for at least 30s. Each DCB catheter can be used once only.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bin Liu, Doctor
- Phone Number: 13500810268
- Email: liubin3333@vip.sina.com
Study Contact Backup
- Name: Longbo Li
- Phone Number: 13069245021
- Email: liangpa123@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- At the age of 18-80 (18 and 80 included)
- The female at reproductive age shouldn't get pregnant or plan to get pregnant during the research
- Patients must agree to accept 3-month angiography follow-up
- Patients must agree to accept clinical follow-up on 30-day, 60-day and 90-day after operation
- Psychologically and linguistically, patients could have an understanding of the research purpose, revealing sufficient compliance with the research proposal. The patients' provision of the informed consent represents that the patient accepts the risks and benefits described in the informed consent.
- Target lesion diameter stenosis is ≥50%, and reference vascular diameter is ≥2.75mm
- De novo coronary lesion
- Type A lesion
Exclusion criteria
- Patients with myocardial infarction within one week
- Patients with congestive heart failure or severe NYHAIV heart failure
- Patients with severe valvular heart disease
- The female in pregnancy or lactation period
- Patients whose life expectancy don't exceed 1 year or who might have difficulty in clinical follow-up
- Patients who are of bleeding physique or forbidden to administer anticoagulants or antiplatelet drugs
- Patients who suffered from cerebral stroke within 6 months prior to surgery
- Patients who are involved in any other clinical trials
- Patients who fail to satisfy angiography conditions due to currently suffering from or previously undergoing severe renal failure (GFR<30ml/min)
- Patients who underwent heart transplantation
- Patients who are deemed inappropriate for inclusion by the researcher due to other reasons
- Lesion of left main coronary artery
- Double vessel or triple vessel disease needed to be interventional treated
- Double vessel or triple vessel disease needed to be interventional treated
- Patients who are intolerant of aspirin and/or clopidogrel, have the medical history of neutrocytopenia or thrombocytopenia, or are forbidden to administer clopidogrel due to severe hepatic insufficiency
- Patients with known hypersensitivity
- Patients with the history of leukopenia (white blood cell count<3x109/L for over 3 days), or neutrocytopenia (ANCs <1,000 neutrophils/mm3 for over 3 days) or thrombocytopenia (blood platelets<100,000/mm3)
- Patients having the history of peptic ulcer or gastrointestinal bleeding within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Drug coated balloon
Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
|
Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lumen loss in advanced stage of lesion segments within 3 months
Time Frame: 3 months
|
Lumen loss in advanced stage of lesion segments within 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate)
Time Frame: 3 months
|
3 months
|
Occurrence rate of dissection after procedure
Time Frame: 3 months
|
3 months
|
Binary restenosis rate 3 months after procedure
Time Frame: 3 months
|
3 months
|
Cardiovascular clinical composite endpoints related to device at the time of 30 days, 60 days and 90days after the surgery include cardiac death, target vessel myocardial infarction and target lesion revascularization driven by clinical symptoms,
Time Frame: 3 months
|
3 months
|
Cardiovascular clinical composite endpoints related to patients at the time of 30 days, 60 days and 90 days after the surgery include all-cause mortality, all myocardial infarction and any revascularization
Time Frame: 3 months
|
3 months
|
ARC-defined occurrence rate of thrombotic events (identified, probable and non-excluded thrombosis during acute, subacute and advanced stage)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SecondJilinU-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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