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

January 2, 2024 updated by: Acotec Scientific Co., Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Tongji Hospital, Tongji University School of Medicine
        • Contact:
          • Xuebo Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test DCB group
use the DCB made by Acotec Scientific
Device: test DCB
use paclitaxel coated coronary balloon catheters to treat SVD
Active Comparator: RESTORE DCB group
use the DCB made by CARDIONOVUM GmbH
Device: RESTORE DCB
use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic percent diameter stenosis
Time Frame: at 9 months post-procedure
(1-Segmental minimum lumen diameter [MLD]/ segmental reference vessel diameter [RVD]) ×100%
at 9 months post-procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acotec Scientific Co., Ltd

Collaborators

Shanghai Tongji Hospital, Tongji University School of Medicine

Investigators

  • Principal Investigator: Xuebo Liu, MD, Shanghai Tongji Hospital, Tongji University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOART paclitaxel SVD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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