Drug Eluting Balloon for Treatment of Unstable Angina

Angina, Unstable Clinical Trial

Official title:

Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02760732
• Other study ID #: 301_xnk1
• Status: Recruiting
• Phase: N/A
• First received: February 29, 2016
• Last updated: November 28, 2017
• Start date: November 2015
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2017
• Source: Chinese PLA General Hospital
• Contact: LI BO, MD
• Phone: +8601055499309
• Email: 22401919[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.

Description:

Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients > 18, < 80 years old, with unstable angina

• Single-vessel or double-vessel disease

• Length of target lesion < 25mm

• Diameter of target vessel >2.5mm, < 3.5mm

Exclusion Criteria:

• Left main disease

• Chronic total occlusion

• Severe Tortuosity

• Heavy calcification

• Severe liver failure, moderate or severe kidney failure

• Malignant disease

• Active infectious disease

• Pregnancy or breastfeeding

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable

Intervention

Device:
• drug eluting balloon; cutting balloon
Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.
• drug eluting stent
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.

Locations

Country	Name	City	State
China	The General Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yun Dai Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Target Lumen assessed by optical coherence tomography	A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.	12 months
Secondary	Incidence rate of MACE	MACE include composite of death, myocardial infarction, or target-vessel revascularization	Incidence rate of MACE from baseline to 12 months