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

NCT ID: NCT04626687

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

test DCB group

use the DCB made by Acotec Scientific

Group Type: EXPERIMENTAL

test DCB

Intervention Type: DEVICE

use paclitaxel coated coronary balloon catheters to treat SVD

RESTORE DCB group

use the DCB made by CARDIONOVUM GmbH

Group Type: ACTIVE_COMPARATOR

RESTORE DCB

Intervention Type: DEVICE

use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD

Interventions

test DCB

use paclitaxel coated coronary balloon catheters to treat SVD

Intervention Type: DEVICE

RESTORE DCB

use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: collaborator

Acotec Scientific Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xuebo Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Locations

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuebo Liu, MD

Role: CONTACT

lxb70@hotmail.com

021-56051080

Facility Contacts

Xuebo Liu, MD

Role: primary

Other Identifiers

ACOART paclitaxel SVD

Identifier Type: -

Identifier Source: org_study_id