Very Long Versus Overlapping Stents in Long Coronary Lesions

NCT ID: NCT04738344

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-01

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.

Conditions

Coronary Artery Disease; Chronic Coronary Syndrome; Drug Eluting Stents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous coronary intervention and stent implantation using one long stent

Long coronary lesions will be treated percutaneously with a single long stent (more than 40 mm in length) and intravascular ultrasonography (IVUS) will be done immediately after stent deployment to record the baseline picture

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention and Stent Implantation

Intervention Type: DEVICE

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

Percutaneous coronary intervention and stent implantation using more than one overlapping stents

Long coronary lesions will be treated with more than one overlapping stents and intravascular ultrasonography (IVUS) will be done immediately after stent deployment to record the baseline picture

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention and Stent Implantation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

PCI

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Young Investigator Group of Cardiovascular Research

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed A Sobhy, MD

Role: STUDY_CHAIR

University of Alexandria - Egypt

Amr Zaky, MD

Role: STUDY_DIRECTOR

University of Alexandria - Egypt

Ahmed M El Amrawy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria - Egypt

Locations

University of Alexandria

Alexandria, , Egypt

International Cardiac Center (ICC)

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

YIG0122001

Identifier Type: -

Identifier Source: org_study_id