Chronic Coronary Syndrome, Coronary Artery Disease, Drug Eluting Stents
Conditions
Keywords
IVUS, Drug Eluting Stents, Chronic Coronary Syndrome
Brief summary
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.
Detailed description
Percutaneous coronary intervention (PCI) in diffuse coronary artery disease is still considered a big obstacle for interventional cardiologists. Very long coronary lesions are usually found, and implantation of a single stent was a great problem forcing the operator to do overlapping of several stents. Recently, new stent designs with increasing length are developed and emerging as a great tool for the percutaneous treatment of long lesions. Nowadays, stents up to 60 mm are available to be used in these cases reducing stent overlap. Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention has been shown in clinical trials, registries, and meta-analyses to be associated with a reduction in clinical events after percutaneous coronary intervention; however, IVUS utilization during percutaneous coronary intervention remains low in the United States and worldwide. The impact of IVUS in these complex lesions may be associated with a lower rate of clinical adverse events in comparison with angiography alone. The study will be conducted on forty patients with chronic stable angina on maximal medical treatment who are going to have elective coronary angiography and elective PCI and having one long coronary lesion that is more than 40 mm in length, they will be randomized into either treatment of the lesion with a single very long stent (more than 40 mm in length) or with more than one overlapping stents in 1:1 randomization. Control angiography and IVUS will be done to the 2 groups after 6 months and the major cardiovascular outcomes will be addressed at 1,3 and 6 months follow-up periods.
Interventions
DEVICEPercutaneous Coronary Intervention and Stent Implantation
Percutaneous Coronary Intervention and Stent Implantation will be implanted as recommended by guidelines and according to the standard techniques.
Sponsors
The Young Investigator Group of Cardiovascular Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary angiographic criteria after 6 months of stent deployment | 6 months | Number of participants with any form in-stent restenosis using control coronary angiography at 6 months |
| (IVUS) after 6 months of stent deployment | 6 months | 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 |
| Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months | 6 months | Number of patients with any Major Cardiovascular and Cerebrovascular Events (MACCE) at 6 months of stent deployment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Major Bleeding Event | 6 months | 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 |
Countries
Egypt
Outcome results
None listed