ClinicalTrials.gg
Status unknownNCT03266289Updated Aug 30, 2017

Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab

An observational study in STEMI - ST Elevation Myocardial Infarction and Unstable Angina, sponsored by MA Abdelreheem. Status unknown. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by MA Abdelreheem · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Sex
All
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Study summary

Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE): cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis and occurrence of Unstable angina (UA) with ECG changes and echo findings in the same target vessel in Assiut university Cath. lab.

Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention in Assiut University Cath.lab

Read the detailed description

IntroductionCoronary artery bifurcation lesions comprise one of the more complex lesion subsetsroutinely faced in interventional cardiology, accounting for up to 20% of all coronarydiseases treated by percutaneous coronary intervention (PCI) The technical difficulties inherent in the treatment of bifurcation lesions, associatedwith their lower success and higher complication rates compared with non-bifurcationlesions, have always been the object of intense research activity, with publication ofcontemporary studies in the past few years contributing significantly to the decisionmaking process.Bifurcation lesions are challenging to categorize, since they are variable not only intheir anatomy (location of plaque, plaque burden, angle between branches, site ofbifurcation, and size of branches), but also in the dynamic anatomic changes duringtreatment caused by dissections and carina shift. Despite these challenges complicatingclassification of bifurcation lesions, many definitions have been proposed in an effort tounify this common clinical situation. A coronary bifurcation lesion is defined as (coronary artery narrowing occurringadjacent to, and/or involving, the origin of a significant side branch). A significant sidebranch (SB) is a branch that, if lost, can impact the prognosis of the patient. General different classifications of coronary bifurcation lesions have been proposed, dueto the variety of possible bifurcation lesions, with different technical implications,treatment options, and prognosis. The most used, for its simplicity and reproducibility,is the Medina classification. This classification is based on the presence or absence ofnarrowing >50% on each of the three components of the bifurcation: the main branchproximal (MBP), the main branch distal, and the SB. A value of 0 or 1 is assigned toeach of the three segments in the following order: MBP, main branch distal, and SB. Forexample, a bifurcation lesion involving the MBP and the SB would be defined as 1, 0,1. Seven morphologies are therefore possible. Despite being the most usedclassification, the Medina has several limitations, since it does not consider the plaqueburden, branch diameter, lesion length, bifurcation angles, the presence of ostialdisease, or calcification.

The goal of percutaneous coronary intervention in bifurcation lesions is tomaximize flow in the main branch (MB), maintain flow in the SB, prevent its occlusion,and maximize long-term patency. Data about bifurcational lesions percentage and short term outcome of differenttechniques used in intervention in our cath lab is still unknown.Aim of the study

02

Conditions studied

  • STEMI - ST Elevation Myocardial Infarction
  • Unstable Angina
03

In context

ST Elevation Myocardial Infarction

851 studies on the registry are indexed under ST Elevation Myocardial Infarction; 198 are open to participants now.

This study's planned enrollment of 50 is below the median of 335 across 297 observational studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

This is the only study on the registry with MA Abdelreheem as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will include patients diagnosed as bifurcational coronary arteries Iesion underwent intervention

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with true bifurcational coronary arteries lesion defined as (lesions in which there is more than 50% diameter stenosis in both the parent vessel and the ostium of the side branch arising from the lesion, and both are more than 2.0 mm in diameter by visual estimation) (13) undergoing intervention either urgent or elective in Assiut university Cath. lab during period from September 2017 to September 2018 will be included in this study.

Exclusion criteria

Exclusion Criteria:

    • to PCI of bifurcation lesions would be any patient unwilling to undergo PCI, coronary anatomy that is not amenable to PCI (e.g., small caliber with diffuse disease), intermediate lesions in the absence of symptoms, and/or subjective evidence of ischemia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention

    Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE): cardiac death, myocardial infarction, target vessel revascularization, or stent

    Time frame: 1 year

Secondary outcomes

  1. Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention in Assiut University Cath.lab

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2017; primary completion for Sep 2018, 12 months later.

Of 122 non-industry observational studies under ST Elevation Myocardial Infarction, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 107. This study's planned 12 months is below that.

Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 20 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2017
First posted
Aug 30, 2017
StartEst.
Sep 1, 2017
Primary completionEst.
Sep 1, 2018
CompletionEst.
Dec 30, 2018
Last update
Aug 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03266289
Lead sponsor
MA Abdelreheem
Responsible party
MA Abdelreheem (Resident doctor, Assiut University) — Sponsor-investigator
First posted
Aug 30, 2017
Start date
Sep 1, 2017 (estimated)
Primary completion
Sep 1, 2018 (estimated)
Completion
Dec 30, 2018 (estimated)
Last update
Aug 30, 2017

Study contacts

Mohamed A. Abdelreheem, Residant
Contact
M.naserdrea3@yahoo.com
01119535430
Mohamed A. Abdelhafez, Doctor
Contact
mohamed.abdelhafez@aun.edu.eg
01065889346
Amr A. Youssef, Prof doctor
study director · Assiut University
Mohamed A. Abdelhafez, Doctor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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