DCB in de Novo Coronary Lesion

NCT03691675 | Unknown

• 1 other identifier: SecondJilinU-3
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter \<2.75mm is the indication of drug coated balloon. In the era of traditional coronary artery balloon dilatation, it is believed that muscle fiber of coronary artery great vessels is more abundant than that of small vessels, and elastic recoil and dissection are easier to appear upon dilatation, which will result in acute vascular occlusion and restenosis, so it is not recommended for great vessels to only receive PTCA therapy. But for patients with good angiography result without combination of serious dissections after predilation, the acute thrombosis seems to be a key factor for acute vascular occlusion. Traditional antiplatelet drug doesn't have a good effect, but the application of new-generation antiplatelet drug (clopidogrel, ticagrelor and tirofiban) has greatly reduced the occurrence rate of acute thrombosis. Therefore, under the guarantee of fully antiplatelet action of new-generation antiplatelet drug, for the patients with good angiography result without combination of serious dissections after predilation, Drug coated balloon seems to be an alternative of the stent. This research is to verify the safety and efficacy of Drug coated balloon in de novo coronary artery lesion with vascular diameter ≥2.75mm.

Conditions

Drug-coated Balloon

Keywords

Drug-coated balloon; restenosis; dissection

Outcome Measures

Primary Outcomes (1)

• Lumen loss in advanced stage of lesion segments within 3 months

  Lumen loss in advanced stage of lesion segments within 3 months

  3 months

Secondary Outcomes (6)

• Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate)

  3 months

• Occurrence rate of dissection after procedure

  3 months

• Binary restenosis rate 3 months after procedure

  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,

  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

  3 months

Study Arms (1)

Drug coated balloon

EXPERIMENTAL

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

Device: Drug coated balloon

Interventions

Drug coated balloon DEVICE

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

Drug coated balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Officials

• Bin Liu, Doctor

  Second Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Liu, Doctor

CONTACT

13500810268; liubin3333@vip.sina.com

Longbo Li

CONTACT

13069245021; liangpa123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department

Model Details: 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

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09