NCT04626687

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 6, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

July 1, 2023

Enrollment Period

3.7 years

First QC Date

November 4, 2020

Last Update Submit

January 2, 2024

Conditions

Coronary Disease

Keywords

coronary small vessel diseasesDCB

Outcome Measures

Primary Outcomes (1)

  • Angiographic percent diameter stenosis

    (1-Segmental minimum lumen diameter \[MLD\]/ segmental reference vessel diameter \[RVD\]) ×100%

    at 9 months post-procedure

Secondary Outcomes (4)

  • Acute success

    in the procedure

  • Rate of target lesion failure

    within 12 months post-procedure

  • Diameter stenosis in-device

    at 9 months post-procedure

  • Late lumen loss

    at 9 months post-procedure

Study Arms (2)

test DCB group

EXPERIMENTAL

use the DCB made by Acotec Scientific

Device: test DCB

RESTORE DCB group

ACTIVE COMPARATOR

use the DCB made by CARDIONOVUM GmbH

Device: RESTORE DCB

Interventions

test DCBDEVICE

use paclitaxel coated coronary balloon catheters to treat SVD

test DCB group
RESTORE DCBDEVICE

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

RESTORE DCB group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Xuebo Liu, MD

    Shanghai Tongji Hospital, Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuebo Liu, MD

CONTACT

021-56051080lxb70@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 12, 2020

Study Start

April 6, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 5, 2024

Record last verified: 2023-07

Locations

CN(1)