Coronary Artery Disease Clinical Trial
Official title:
The Use of Very Long Versus Overlapping Drug Eluting Stents for the Management of Long Coronary Artery Lesions
Verified date | October 2022 |
Source | The Young Investigator Group of Cardiovascular Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is performed to compare the angiographic and clinical outcomes of the use of single long stent versus overlapping stents in the treatment of long coronary lesions in patients with chronic coronary syndrome.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients > 18 years of age - Single vessel disease and undergoing PCI for significant long lesion. - Chronic stable angina on maximal medical treatment. Exclusion Criteria: - Patients presenting with acute coronary syndromes. - Patients having two or more vessel disease on coronary angiography. - Previous myocardial infarction. - Previous vascularization either by PCI or bypass grafting. - Very low ejection fraction less than 35%. - Renally impaired patients with Creatinine clearance less than 50 ml/min. - Contraindication to dual antiplatelet drug therapy. - Contraindication to coronary angiography. |
Country | Name | City | State |
---|---|---|---|
Egypt | International Cardiac Center (ICC) | Alexandria | |
Egypt | University of Alexandria | Alexandria |
Lead Sponsor | Collaborator |
---|---|
The Young Investigator Group of Cardiovascular Research |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary angiographic criteria after 6 months of stent deployment | Number of participants with any form in-stent restenosis using control coronary angiography at 6 months | 6 months | |
Primary | (IVUS) after 6 months of stent deployment | Number of participants with any form in-stent restenosis using Intravascular Ultrasonography (IVUS) at 6 months to assess subclinical neointimal proliferation and in-stent restenosis | 6 months | |
Primary | Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months | Number of patients with any Major Cardiovascular and Cerebrovascular Events (MACCE) at 6 months of stent deployment | 6 months | |
Secondary | Any Major Bleeding Event | Number of patients with Any Major Bleeding Event as defined by the International Society of Thrombosis and Haemostasis (fatal bleeding, and/or symptomatic bleeding in a critical organ or area, and/or bleeding causing a fall in hemoglobin level of = 2 g/dl or 1.24 mmol/L | 6 months |
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