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Drug-coated Balloons in Big de Novo Coronary Disease (DCB-LVD)

Primary Purpose

Coronary Heart Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

drug-coated balloon

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring drug-coated balloon, de novo coronary disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Over 18 years old;
Asymptomatic myocardial ischemia, stable or unstable angina;
The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.

Exclusion Criteria:

Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
Life expectancy is less than 12 months;
eGFR≤30ml/min/1.73m2 or blood purification treatment;
LVEF≤40% or NYHA cardiac function class≥III;
Clinical conditions of severe hepatic insufficiency and coagulation disorder
Pregnant or breastfeeding women;
Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
Reference lumen diameter > 4.0mm;
Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion;
The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy;
Chronic total occlusive disease;
Left main stem disease;
Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions;
Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing

Sites / Locations

Beijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

DCB treatment

DES treatment

Arm Description

drug-coated balloon in PCI

drug-eluted stent in PCI

Outcomes

Primary Outcome Measures

late lumen loss，LLL

late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI

Secondary Outcome Measures

target lesion failure，TLF

Cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization or target vessel revascularization

Full Information

NCT ID

NCT05550233

First Posted

September 19, 2022

Last Updated

February 6, 2023

Sponsor

Beijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05550233

Brief Title

Drug-coated Balloons in Big de Novo Coronary Disease

Acronym

DCB-LVD

Official Title

A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

drug-coated balloon, de novo coronary disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DCB treatment

Arm Type

Experimental

Arm Description

drug-coated balloon in PCI

Arm Title

DES treatment

Arm Type

Other

Arm Description

drug-eluted stent in PCI

Intervention Type

Device

Intervention Name(s)

drug-coated balloon

Other Intervention Name(s)

drug-eluted stent

Intervention Description

drug-coated balloon in big de novo coronary disease

Primary Outcome Measure Information:

Title

late lumen loss，LLL

Description

late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI

Time Frame

12 months after PCI

Secondary Outcome Measure Information:

Title

target lesion failure，TLF

Description

Cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization or target vessel revascularization

Time Frame

12 months after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 18 years old; Asymptomatic myocardial ischemia, stable or unstable angina; The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation; Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months; The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm. Exclusion Criteria: Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months; Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol; Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants; Life expectancy is less than 12 months; eGFR≤30ml/min/1.73m2 or blood purification treatment; LVEF≤40% or NYHA cardiac function class≥III; Clinical conditions of severe hepatic insufficiency and coagulation disorder Pregnant or breastfeeding women; Participating in another clinical trial and have not completed the primary endpoint observation of the trial; Reference lumen diameter > 4.0mm; Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion; The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy; Chronic total occlusive disease; Left main stem disease; Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions; Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinyue Wang, MD

Phone

08613651366634

pekingcner@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xue Yu, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fusui Ji, MD

Organizational Affiliation

Beijing Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinyue Wang, MD

Phone

08613651366634

pekingcner@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Published papers

Learn more about this trial

Drug-coated Balloons in Big de Novo Coronary Disease

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