Very Long Versus Overlapping Stents in Long Coronary Lesions

The Use of Very Long Versus Overlapping Drug Eluting Stents for the Management of Long Coronary Artery Lesions

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Chronic Coronary Syndrome; Drug Eluting Stents
• Intervention / Treatment: Device: Percutaneous Coronary Intervention and Stent Implantation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21321
    • University of Alexandria
  • Alexandria, Egypt, 21524
    • International Cardiac Center (ICC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: PCI
Experimental: 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	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.; Other Names: PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
(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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Young Investigator Group of Cardiovascular Research
• Investigators: Study Chair: Mohamed A Sobhy, MD, University of Alexandria - Egypt; Study Director: Amr Zaky, MD, University of Alexandria - Egypt; Principal Investigator: Ahmed M El Amrawy, MD, University of Alexandria - Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: IVUS; Drug Eluting Stents; Chronic Coronary Syndrome
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: YIG0122001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD may be shared with researchers if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No