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Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions (BJDCB-BIF)

Primary Purpose

Coronary Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Paclitaxel DCB

DES

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Angioplasty, drug-coated balloon, bifurcation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient-related criteria：
- Patients with stable angina, unstable angina, old myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy;
- Aged between 18 and 80 years;
- Consent to receive angiographic follow up at 9 months and clinical follow up at 30 days, 6, 9, 12 and 24 months.
Lesion-related criteria：
- Target lesions of Medina (0,1,1), (1,0,1) or (1,1,1) primary coronary bifurcation lesions without previous intervention therapy;
- MB reference vessel diameter between 2.5 mm and 3.5 mm and length ≤30mm; SB reference vessel diameter between 2.0 mm and 3.0 mm and length ≤22 mm;
- Pre-operative vessel diameter stenosis must ≥70% or ≥50% associated with local ischemia;
- After lesion predilation, no dissection is seen, or type A/B dissection can be seen, residual stenosis ≤30% and TIMI(thrombolysis in myocardial infarction) grade 3 flow;
- The distance between other lesions requiring intervention therapy and the target lesion must >10mm ;
- Only one drug-eluting balloon or drug-eluting stent is used in treatment of MB and SB lesions.

Exclusion Criteria:

Patient-related criteria：
- Myocardial infarction in the previous week;
- Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)]
- Severe valvular heart disease;
- Pregnant or breastfeeding women;
- Life expectancy no more than 1 year or factors causing difficulties in clinical follow up;
- Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents;
- Intolerance to aspirin and/or clopidogrel;
- Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy;
- Leukopenia or thrombopenia;
- A history of peptic ulcer or GI bleeding in the previously;
- Stroke within 6 months prior to the operation;
- A history of severe hepatic or renal failure.
Lesion-related criteria ：
- Extensive thrombosis in the target vessel;
- Percutaneous coronary intervention of the graft vessel;
- Chronic total occlusions (pre-operative TIMI grade 0 flow);
- Left main branch lesions and /or three-vessel lesions requiring treatment;
- Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

Sites / Locations

Beijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel DCB for MB and/or SB

DES in MB

Arm Description

Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for >30 seconds

with regular techniques

Outcomes

Primary Outcome Measures

QCA(quantitative coronary analysis) of efficacy of DCB

late lumen loss, minimal lumen diameter

Secondary Outcome Measures

device-related ischemic events

including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization

patient-related ischemic events

all myocardial infarction , any revascularization and all-cause death

ARC（Academic Research Consortium） defined target vessel thrombus events

definite, probable and possible target vessel thrombus

Full Information

NCT ID

NCT03223974

First Posted

July 15, 2017

Last Updated

March 21, 2022

Sponsor

Beijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03223974

Brief Title

Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

Acronym

BJDCB-BIF

Official Title

Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 16, 2017 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

February 28, 2021 (Actual)

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.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation lesions when compared with traditional single drug eluting stent(DES) strategy, so as to simplify the procedure for treatment of coronary bifurcation lesions and extending the clinical indications of paclitaxel DCB in China.

Detailed Description

Paclitaxel DCB is designed to release anti-proliferative agents to the whole lesion rapidly and homogenously to inhibit excessive neointima proliferation and is associated with rapid healing of endothelium. As a result, DCB therapy reduces the risk of coronary thrombosis. Since only 1 to 3 months duration of dual anti-platelet therapy is required, the bleeding risk associated with prolonged dual anti-platelet therapy (DAPT) is reduced by DCB. Furthermore, there is no permanent residue of foreign bodies in the blood vessels after DCB procedure and this advantage completely eliminates adverse events associated with allergic reactions to metal, polymer and stent fracture. For side branch(SB) with a relatively small lumen in bifurcation lesions, DCB may neglect the lumen loss due to stent scaffolds and cause much less late lumen loss (LLL) than stent therapy does. For main branch(MB), no jailed SBs by the stent and the rate of SB stenosis or even occlusion will be greatly reduced.

6. Conditions and Keywords

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

Coronary Disease

Keywords

Angioplasty, drug-coated balloon, bifurcation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel DCB for MB and/or SB

Arm Type

Experimental

Arm Description

Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for >30 seconds

Arm Title

DES in MB

Arm Type

Active Comparator

Arm Description

with regular techniques

Intervention Type

Device

Intervention Name(s)

Paclitaxel DCB

Intervention Description

Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for >30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.

Intervention Type

Device

Intervention Name(s)

DES

Intervention Description

MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.

Primary Outcome Measure Information:

Title

QCA(quantitative coronary analysis) of efficacy of DCB

Description

late lumen loss, minimal lumen diameter

Time Frame

Follow-up coronary angiography at 9 months after the procedure

Secondary Outcome Measure Information:

Title

device-related ischemic events

Description

including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization

Time Frame

Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure

Title

patient-related ischemic events

Description

all myocardial infarction , any revascularization and all-cause death

Time Frame

Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation

Title

ARC（Academic Research Consortium） defined target vessel thrombus events

Description

definite, probable and possible target vessel thrombus

Time Frame

Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient-related criteria： Patients with stable angina, unstable angina, old myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy; Aged between 18 and 80 years; Consent to receive angiographic follow up at 9 months and clinical follow up at 30 days, 6, 9, 12 and 24 months. Lesion-related criteria： Target lesions of Medina (0,1,1), (1,0,1) or (1,1,1) primary coronary bifurcation lesions without previous intervention therapy; MB reference vessel diameter between 2.5 mm and 3.5 mm and length ≤30mm; SB reference vessel diameter between 2.0 mm and 3.0 mm and length ≤22 mm; Pre-operative vessel diameter stenosis must ≥70% or ≥50% associated with local ischemia; After lesion predilation, no dissection is seen, or type A/B dissection can be seen, residual stenosis ≤30% and TIMI(thrombolysis in myocardial infarction) grade 3 flow; The distance between other lesions requiring intervention therapy and the target lesion must >10mm ; Only one drug-eluting balloon or drug-eluting stent is used in treatment of MB and SB lesions. Exclusion Criteria: Patient-related criteria： Myocardial infarction in the previous week; Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)] Severe valvular heart disease; Pregnant or breastfeeding women; Life expectancy no more than 1 year or factors causing difficulties in clinical follow up; Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents; Intolerance to aspirin and/or clopidogrel; Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy; Leukopenia or thrombopenia; A history of peptic ulcer or GI bleeding in the previously; Stroke within 6 months prior to the operation; A history of severe hepatic or renal failure. Lesion-related criteria ： Extensive thrombosis in the target vessel; Percutaneous coronary intervention of the graft vessel; Chronic total occlusions (pre-operative TIMI grade 0 flow); Left main branch lesions and /or three-vessel lesions requiring treatment; Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xue Yu, 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

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