Back to results

Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions (DCB-BIF)

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Drug-coating balloon

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

Subject must be age ≥18 years.
Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed.
Subject is willing to comply with all protocol-required follow-up evaluations.
Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation.
Target lesion must have visually estimated stenosis ≥50%.
Target lesion length of side branch must be <10 mm by visual estimation.
Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.

Exclusion Criteria:

Patient with STEMI (within 1-week from the onset of chest pain to admission).
Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
Patient is intolerable to dual anti-platelet therapy.
Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
Patient is pregnant or nursing.
Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
Restenotic lesion.
Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized.
Severe calcification needing rotational atherectomy.

Sites / Locations

Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PS-DCB

PS-NCB

Arm Description

For PS-DCB group NC balloon dilating ostial side branch (SB) (1:1 ratio). DCB dilating SB. Specifically, the DCB, which had to be 2-3 mm longer on each side than the predilatation balloon, was inflated at nominal pressure for 30~ 60 s. The ratio of the DCB diameter to the nominal diameter of the SB was recommended to be between 0.8 and 1.0. DCB should be delivered to the lesion within 2 min after entering human body. Kissing inflation using 2 noncomplian balloons. Stenting side branch with T and protrusion (TAP) technique if any of the following issues was observed after kissing balloon inflation: >type C dissection or thrombolysis in myocardial infarction (TIMI) flow <3. Final kissing inflation and proximal optimal technique (POT).

For PS-NCB group NC balloon dilating ostial SB (1:1 ratio). Kissing inflation using 2 NC balloons. Stenting side branch with TAP technique if any of the following issues was observed after kissing balloon inflation: >type C dissection or thrombolysis in myocardial infarction (TIMI) flow <3. Final kissing inflation and proximal optimal technique (POT).

Outcomes

Primary Outcome Measures

Rate of major adverse cardiac event

MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.

Secondary Outcome Measures

Rate of all-cause death or cardiac death

In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.

Rate of periprocedural MI, Spontaneous MI, or target vessel MI

According to the DCB-BIF trial definition.

Rate of clinically-driven TLR or TVR

Clinically driven revascularization includes repeat PCI or coronary artery bypass graft (CABG) for recurrent or persistent symptomatic ischemia and can be defined according to the relationship to the index PCI (target lesion).

Rate of thrombosis

The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.

Full Information

NCT ID

NCT04242134

First Posted

January 20, 2020

Last Updated

May 14, 2023

Sponsor

Nanjing First Hospital, Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04242134

Brief Title

Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions

Acronym

DCB-BIF

Official Title

Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.

Detailed Description

This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments. All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.

6. Conditions and Keywords

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

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients will undergo 1:1 randomization to either PS-DCB which will be the treatment group or PS-NCB which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee, Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.

Masking

Outcomes Assessor

Masking Description

Outcomes assessor will remain blinded until the final study results are released.

Allocation

Randomized

Enrollment

784 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PS-DCB

Arm Type

Experimental

Arm Description

Arm Title

PS-NCB

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Drug-coating balloon

Other Intervention Name(s)

DCB

Intervention Description

Provisional stenting technique with DCB

Primary Outcome Measure Information:

Title

Rate of major adverse cardiac event

Description

MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.

Time Frame

12 months after angioplasty

Secondary Outcome Measure Information:

Title

Rate of all-cause death or cardiac death

Description

In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.

Time Frame

12 months after angioplasty

Title

Rate of periprocedural MI, Spontaneous MI, or target vessel MI

Description

According to the DCB-BIF trial definition.

Time Frame

12 months after angioplasty

Title

Rate of clinically-driven TLR or TVR

Description

Time Frame

12 months after angioplasty

Title

Rate of thrombosis

Description

The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.

Time Frame

12 months after angioplasty

Other Pre-specified Outcome Measures:

Title

Rate of Angiographic success

Description

PCI is considered successful for lesions treated with stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 10% and the final TIMI flow grade is 3. PCI is considered successful for lesions treated without stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 20% and the final TIMI flow grade is 3.

Time Frame

1 day

Title

Rate of clinical procedural success

Description

Successful PCI without MACE during hospital stay.

Time Frame

7 day

Title

Crossover rate

Description

From single stent technique to two-stent technique

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject must be age ≥18 years. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed. Subject is willing to comply with all protocol-required follow-up evaluations. Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation. Target lesion must have visually estimated stenosis ≥50%. Target lesion length of side branch must be <10 mm by visual estimation. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel. Exclusion Criteria: Patient with STEMI (within 1-week from the onset of chest pain to admission). Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications. Patient is intolerable to dual anti-platelet therapy. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. Patient is pregnant or nursing. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Restenotic lesion. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized. Severe calcification needing rotational atherectomy.

Central Contact Person:

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

Shao-Liang Chen, MD, PhD

Phone

+86-25-52208048

chmengx@126.com

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

Jing Kan, MPH

Phone

+86-25-52271398

kanjingok@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shao-Liang Chen, MD, PhD

Organizational Affiliation

Nanjing First Hospital, Nanjing Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Nanjing First Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shaoliang Chen, MD

Phone

+86 13605157029

chmengx@126.com

First Name & Middle Initial & Last Name & Degree

Jing Kan, MPH

Phone

+86 15305140515

kanjingok@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35277400

Citation

Gao XF, Ge Z, Kan J, Kong XQ, Wang Y, Qiu CG, Tresukosol D, He YQ, Wu Q, Li JF, Yuan HT, Shen C, Chen X, Munawar M, Hanif B, Santoso T, Shin ES, Sheiban I, Ye F, Zhang JJ, Chen SL; DCB-BIF investigators. Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial. BMJ Open. 2022 Mar 11;12(3):e052788. doi: 10.1136/bmjopen-2021-052788.

Results Reference

derived

Learn more about this trial

Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions

We'll reach out to this number within 24 hrs