Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions (DCB)

May 22, 2023 updated by: ahmed hassan, Ain Shams University
● 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

Age & sex. Family history. Smoking status. Medical history including hypertension (HTN), diabetes mellitus (DM), renal impairment, etc.

Previous history of coronary artery disease, myocardial infarctions (MI), revascularization procedures Medical treatment and any significant history of allergy Previous intervention history regarding (site, type, diameter and length of the stent , complications and TIMI flow ) if available

General &Physical examination:

with special emphasis on vital data, decubitus ,lung osculation and peripheral pulsation

Laboratory investigations:

Including kidney function, complete blood count, and High sensitive troponin in case of acute coronary syndrome Echocardiography will be done routinely for all patients with special emphasis on ejection fraction (to be assessed by modified Simpson's method), left ventricular dimensions, resting segmental wall motion abnormalities (RSWMAs).

Interventional procedure. Angiographic analysis. Serial coronary angiography will be performed at baseline (before and after intervention) and angiograms will be obtained in multiple views after intra-coronary nitrate if coronary spasm is suspected. coronary angiograms will be digitally recorded and analyzed by experienced personnel using a validated offline quantitative angiographic system and the following data will be collected: -

Bifurcation lesion distribution:

Left main artery bifurcation Left anterior descending artery/diagonal bifurcation Left circumflex artery/obtuse marginal bifurcation Right coronary artery/posterolateral branch

Medina classification the investigators will use Medina classification for coronary bifurcation lesion in which recording any narrowing more than 50% in each of the three arterial segments of the bifurcation in the following order: proximal main vessel (PMV). Distal main branch (DMV). Side branch (SB)

(1) is used to indicate the presence of a significant stenosis and (0) the absence of stenosis

Main vessel

Proximal reference diameter (mm) Distal reference diameter (mm) Mean reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%)) Lesion length (mm) Angiographic restenosis (%)

Side branch

Reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%) Lesion length (mm)

Type of drug-eluting stents Sirolimus-eluting stents Everolimus-eluting stents Zotrolimus-eluting stents Biolimus A9-eluting stent Number of stent/drug-eluting balloon used Stent/drug-eluting balloon size (mm) Stent/drug-eluting balloon length (mm) Maximum balloon size (mm) Maximum inflation pressure (atmosphere) other coronary lesions

Intervention

  1. wire both branches, MV and SB, with two coronary guide wires.
  2. Main branch pre-dilation
  3. Side branch pre-dilation using (ordinary balloon in group "A" and Drug coated balloon in group "B" for the side branch)
  4. Main vessel stenting
  5. Proximal optimization technique (POT) of the main vessel stent

The following data will be recorded: -

  1. Inflation time (Seconds.)
  2. Inflation pressure (atmospheric pressure.)
  3. Diameter of the stent after inflation
  4. Time of the procedure After Intervention

1) Reference luminal diameter (mm) 2) Minimal luminal diameter in stent (mm) 3) Minimal luminal diameter in lesion (mm) 4) lesion success (attainment of >50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis) 5) procedure success (attainment of a final lesion success and no major angiographic complications as dissection or perforation ).

Post-procedural Medications will be prescribed according to 2018 ESC myocardial revascularization guidelines.

Patients will be assessed for immediate outcomes:

lesion success attainment of >50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis procedure success attainment of a final lesion success and no major complication as :-

A. Perforation with or without tamponade B. vascular access complications C. myocardial infarction D. contrast-induced nephropathy E. urgent coronary artery bypass grafting F. urgent repeat PCI G. Death.

Patients be assessed and monitor for 24 hours after the procedure and in the outpatient clinic after 6 months.

Follow up clinically after 6 months for MACEs

Study end points. Primary end point target is 6-month follow-up for:-

MACEs (major adverse cardiac events) defined as :-

  1. Death
  2. Non-fatal myocardial infarction
  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"
  4. Stroke

Improvement or recurrence of symptoms (chest pain and dyspnea) Symptomatic patients will undergo coronary angiography and those who has no symptoms with undergo functional assessment using either (High dose dobutamine echo or Myocardial perfusion imaging )

Secondary end points included:

lesion success procedure success

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 002
        • Recruiting
        • Ainshams university , Faculty of Medicine
        • Contact:
          • Yousef Amin, MD
          • Phone Number: 01001737008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Patients with age above 18 years indicated for elective coronary angiography according to ESC 2018 guidelines with a bifurcation lesion affected Side branch (SB)
  2. Patient Who planned for provisional stenting technique from the start or shifted to 2-stent strategy as a bailout to the Side branch
  3. Bifurcation lesion with medina classification (1,1,1), (1,0,1) and (0,1,1)

Exclusion criteria:

Angiographical exclusion criteria as follows

  1. Medina classification (1,1,0) or (0,1,0) or (1,0,0)
  2. Side branch less than 2 mm in diameter
  3. Patients who have multiple lesions with high syntax score and clinical characteristics favoring coronary artery bypass grafting according to latest ESC guidelines 2018.
  4. Need for concomitant valvular surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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
Diagnostic test: Coronary angiography plus percutenous coronary intervention
  1. wire both branches, MV and SB, with two coronary guide wires.
  2. Main branch pre-dilation
  3. Side branch pre-dilation using (ordinary balloon in group "A" and Drug coated balloon in group "B" for the side branch)
  4. Main vessel stenting
  5. Proximal optimization technique (POT) of the main vessel stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 monthes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion and procedure
Time Frame: 6 monthes

lesion success (Measured by attainment of >50% in- stent residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis) Attainment >50 % = 0 For 10% to 50 % = 1 Less than 10% = 2

- procedure success (Measured as attainment of a final lesion success > 50% and no major complications as dissection or perforation ) No complication = 0 Any major complication= 1 . Each participants will take (0), (1) or (2) for each outcome
6 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed Hassan, MSc, Ain shams university , cardiology department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 4, 2023

Primary Completion (Anticipated)

October 11, 2023

Study Completion (Anticipated)

October 11, 2023

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CardioAinShams

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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