A Study of Drug Coated Balloon For Treating the Side Branch in Complex Bifurcation Lesions

NCT05222061 | Unknown

• 1 other identifier: 01-45
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: In patients undergoing coronary stenting for the true bifurcation lesions, main branch stenting followed by side branch dilatation with drug coated balloon is superior to the provisional-stenting strategy in terms of late lumen loss at 12 months.

Conditions

Coronary Artery Disease

Keywords

Drug coated balloon, coronary bifurcation

Outcome Measures

Primary Outcomes (1)

• Late lumen loss for both main branch and side branch

  Measured by quantitative coronary angiography.

  12 months

Secondary Outcomes (9)

• Major Adverse Cardiac Events (MACE)

  3,6,12 months

• All-cause death

  3,6,12 months

• Stent/vessel thrombosis

  3,6,12 months

• Angiographic Binary Restenosis

  12 months

• Target Lesion Revascularization

  3,6,12 months

Study Arms (2)

provisional-stenting group

ACTIVE COMPARATOR

Provisional stenting will be performed according to european bifurcation club consensus. MB and SB predilatation will be at the operator's discretion. A stent is delivered in the main vessel and positioned across the bifurcation. POT is mandatotary. In case of dissection impeding the flow in the SB or acute coronary closure after MB atenting a SB stenting using a DES was allowed. Dual-stent techniques will be performed according to the recommendation of the EBC consensus.

Device: Conventional balloon for the side brunch

DCB group

EXPERIMENTAL

Coronary guidewires should be passed to the MB and SB, respectively. Lesion preparation of the main branch should be undertaken as considered necessary. Lesion preparation of the side branch is mandatorary. If the angiographic result will be good after predilatation (residual stenosis \< 30%), drug-eluting stent will implanted in the main branch of the bifurcation site (the stent diameter should be choosen based on the diameter of the distal MB). A kissing with conventional balloons should be performed in the MB and SB. Reapet kissing with drug-coated balloonin the SB and conventional balloon in MB (30 seconds at low pressure (8-10 bar) should be performed. The DCB diameter was again 0.8-1.0 of the vessel diameter. In case of dissection impeding the flow in the SB or acute coronary closure after DCB application a SB stenting using a DES was allowed. Dual-stent techniques will be performed according to the recommendation of the EBC consensus.

Device: Drug coated balloon for the side brunch

Interventions

Drug coated balloon for the side brunch DEVICE

Intervention is explained in group description

DCB group

Conventional balloon for the side brunch DEVICE

Intervention is explained in group description

provisional-stenting group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main branch and side branch diameter both \>2.5 mm, evaluated based on coronary angiography, performed no later than 6 month before baseline visit;
• Patient ≥18 years old;
• Signed informed consent;
• True bifurcation lesion type 1:1:1 or 0:1:1 or 1:0:1 and
• ischemic symptoms, or
• positive non-invasive imaging for ischemia, or
• positive fractional flow reserve

You may not qualify if:

• ST Elevation Miocardial Infarction \<72 hours preceding;
• Cardiogenic shock;
• Chronic total occlusion of either main or side branch of the bifurcation;
• \>2 other coronary lesions planned for treatment;
• SYNTAX score \>32;
• Left main stenosis;
• In-stent restenosis;
• Renal function insufficiency: Serum creatinine \> 177 mmol/l; or undergoing hemodialysis;
• Left ventricular ejection fraction ≤ 30%;
• Patient life expectancy less than 12 months;
• Patient's inability to fully cooperate with the study protocol

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin National Medical Research Center

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Dmitrii Khelimskii, MD, PhD

CONTACT

+79137069256; dkhelim@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: February 3, 2022
• Study Start: February 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)