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

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ClinicalTrials.gov Identifier: NCT03266289
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
MA Abdelreheem, Assiut University

Brief 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


Condition or disease
STEMI - ST Elevation Myocardial Infarction Unstable Angina

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


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack




Primary Outcome Measures :
  1. Primary aim: evaluation of the short term outcome of different techniques used in bifurcational coronary arteries intervention [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention in Assiut University Cath.lab [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

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:

  • • Contraindications 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266289


Contacts
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Contact: Mohamed A. Abdelreheem, Residant 01119535430 M.naserdrea3@yahoo.com
Contact: Mohamed A. Abdelhafez, Doctor 01065889346 mohamed.abdelhafez@aun.edu.eg

Sponsors and Collaborators
MA Abdelreheem
Investigators
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Study Director: Amr A. Youssef, Prof doctor Assiut University
Study Director: Mohamed A. Abdelhafez, Doctor Assiut University

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Responsible Party: MA Abdelreheem, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03266289     History of Changes
Other Study ID Numbers: 17100301
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms