Very Long Versus Overlapping Stents in Long Coronary Lesions

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04738344
• Other study ID #: YIG0122001
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: The Young Investigator Group of Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Coronary Artery Disease
• Drug Eluting Stents

Intervention

Device:
• Percutaneous Coronary Intervention and Stent Implantation
Percutaneous Coronary Intervention and Stent Implantation will be implanted as recommended by guidelines and according to the standard techniques.

Locations

Country	Name	City	State
Egypt	International Cardiac Center (ICC)	Alexandria
Egypt	University of Alexandria	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
The Young Investigator Group of Cardiovascular Research

Country where clinical trial is conducted

Egypt, 

Outcome

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