ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

Coronary Disease Clinical Trial

Official title:

Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626687
• Other study ID #: ACOART paclitaxel SVD
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Acotec Scientific Co., Ltd
• Contact: Xuebo Liu, MD
• Phone: 021-56051080
• Email: lxb70[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.

Description:

This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 to 80 years of age

• Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator

• Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) = 2.00 mm and = 2.75 mm, and = 26 mm in length.

• Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.

• Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.

Exclusion Criteria:

• AMI within 1 week.

• Subject has congestive heart failure or NYHA IV.

• Subject with LVEF < 35%.

• Subject has undergone heart transplantation.

• Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.

• Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding.

• Subject with a history of leukopenia (white blood cell count of < 3×109/L for >3 days), neutropenia (ANC<1000/mm3 for >3 days) or thrombocytopenia (platelet <100,000/mm3).

• Known renal insufficiency (eGFR<30 ml/min).

• Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel.

• Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up.

• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.

• Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.

• Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases.

• Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch = 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Device:
• test DCB
use paclitaxel coated coronary balloon catheters to treat SVD
• RESTORE DCB
use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd	Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic percent diameter stenosis	(1-Segmental minimum lumen diameter [MLD]/ segmental reference vessel diameter [RVD]) ×100%	at 9 months post-procedure
Secondary	Acute success	Including instrument success rate, lesion success rate and surgical success rate	in the procedure
Secondary	Rate of target lesion failure	A composite of cardiac death, target-vessel related myocardial infarction, and ischemia-driven target lesion revascularization	within 12 months post-procedure
Secondary	Diameter stenosis in-device	(1-the minimum cavity diameter of the device [MLD] / the reference vessel diameter of the device [RVD]) ×100%	at 9 months post-procedure
Secondary	Late lumen loss	Loss of late lumen in the segment and device	at 9 months post-procedure