Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- MACE (Number of participants complains of one of MACE )
Study Overview
Brief Summary
● the investigators aims to study the impact of using drug coated balloon in coronary artery bifurcation lesions on the procedural success rate & short-term MACE.
Detailed Description
Study Design:
A prospective study. Patients who met the inclusion criteria will be enrolled in our study will be subdivided into 2 groups :-
Group A: patient Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty Group B: patient Who will undergo provisional stenting using Drug coated balloon The patients will be randomly assigned for each group using a computer randomizing software application.
Both group with pass 3 stages: - Pre-procedural Interventional procedure Post -procedural Pre- procedural
History taking:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with age above 18 years indicated for elective coronary angiography according to ESC 2018 guidelines with a bifurcation lesion affected Side branch (SB)
- •Patient Who planned for provisional stenting technique from the start or shifted to 2-stent strategy as a bailout to the Side branch
- •Bifurcation lesion with medina classification (1,1,1), (1,0,1) and (0,1,1)
Exclusion Criteria
- •Angiographical exclusion criteria as follows
- •Medina classification (1,1,0) or (0,1,0) or (1,0,0)
- •Side branch less than 2 mm in diameter
- •Patients who have multiple lesions with high syntax score and clinical characteristics favoring coronary artery bypass grafting according to latest ESC guidelines
- •Need for concomitant valvular surgery
Arms & Interventions
Conventional balloon
patients Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty wire both branches, MV and SB, with two coronary guide wires. Main branch pre-dilation Side branch pre-dilation using ordinary balloon for the side branch) Main vessel stenting Proximal optimization technique (POT) of the main vessel stent
Drug coated balloon
patients Who will undergo provisional stenting using Drug coated balloon (paclitaxel-coated balloon (PCB)) wire both branches, main vessel and side branch, with two coronary guide wires.
Main branch pre-dilation Side branch pre-dilation using Drug coated balloon (paclitaxel-coated balloon for the side branch Main vessel stenting Proximal optimization technique (POT) of the main vessel stent
Intervention: Coronary angiography plus percutenous coronary intervention (Diagnostic Test)
Outcomes
Primary Outcomes
MACE (Number of participants complains of one of MACE )
Time Frame: 6 monthes
Primary end point target is 6-month follow-up for:- o MACEs (major adverse cardiac events) defined as :- 1. Death. (Measured as death or No death) 2. Non-fatal myocardial infarction (defined according to ESC guidelines as the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia ). Measured as occurrence of events or not 3. Target lesion re-vascularization (TLR) "defined as any clinically driven intervention (surgical or percutaneous) to the target lesion or any segment of the epicardial coronary artery containing the target lesion". Measured as need of revascularization by percutenous coronary intervention or coronary artery bypass grafting or not 4. Stroke (loss of blood flow to part of the brain, which damages brain tissue transiently or permanently approved by clinical symptoms and imaging ( confirmed by CT or MRI) measured by occurrence of stroke or not
Secondary Outcomes
- Lesion and procedure(6 monthes)
Investigators
ahmed hassan
Assistant lecturer
Ain Shams University