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Very Long Versus Overlapping Stents in Long Coronary Lesions

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ClinicalTrials.gov Identifier: NCT04738344
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
The Young Investigator Group of Cardiovascular Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Chronic Coronary Syndrome Drug Eluting Stents Device: Percutaneous Coronary Intervention and Stent Implantation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Very Long Versus Overlapping Drug Eluting Stents for the Management of Long Coronary Artery Lesions
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : March 1, 2022
Arms and Interventions
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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 Name: 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 Name: PCI


Outcome Measures
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Primary Outcome Measures :
  1. Coronary angiographic criteria after 6 months of stent deployment [ Time Frame: 6 months ]
    Number of participants with any form in-stent restenosis using control coronary angiography at 6 months

  2. (IVUS) after 6 months of stent deployment [ Time Frame: 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

  3. Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months [ Time Frame: 6 months ]
    Number of patients with any Major Cardiovascular and Cerebrovascular Events (MACCE) at 6 months of stent deployment


Secondary Outcome Measures :
  1. Any Major Bleeding Event [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738344


Contacts
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Contact: Ahmed M El Amrawy, MD +201006222922 dr.ahmed.elamrawy@hotmail.com
Contact: Ahmed Naguib, MSc +201003756413 drahmednaguib@hotmail.com

Locations
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Egypt
University of Alexandria Recruiting
Alexandria, Egypt, 21321
Contact: Ahmed Naguib, MSc    +201003756413    drahmednaguib@hotmail.com   
Principal Investigator: Ahmed M El Amrawy, MD         
Sub-Investigator: Ahmed Naguib, MSc         
Sub-Investigator: Abdallah Almaghraby, Msc         
International Cardiac Center (ICC) Recruiting
Alexandria, Egypt, 21524
Contact: Ahmed El Amrawy, MD    +201006222922    dr.ahmed.elamrawy@hotmail.com   
Principal Investigator: Ahmed M El Amrawy, MD         
Sub-Investigator: Ahmed Naguib, MSc         
Sponsors and Collaborators
The Young Investigator Group of Cardiovascular Research
Investigators
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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
More Information
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Responsible Party: The Young Investigator Group of Cardiovascular Research
ClinicalTrials.gov Identifier: NCT04738344    
Other Study ID Numbers: YIG0122001
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD may be shared with researchers if requested

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Young Investigator Group of Cardiovascular Research:
IVUS
Drug Eluting Stents
Chronic Coronary Syndrome
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases