search
Back to results

Very Long Versus Overlapping Stents in Long Coronary Lesions

Primary Purpose

Coronary Artery Disease, Chronic Coronary Syndrome, Drug Eluting Stents

Status
Withdrawn
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention and Stent Implantation
Sponsored by
The Young Investigator Group of Cardiovascular Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring IVUS, Drug Eluting Stents, Chronic Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alexandria
  • International Cardiac Center (ICC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Percutaneous coronary intervention and stent implantation using one long stent

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
(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
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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2020
Last Updated
October 4, 2022
Sponsor
The Young Investigator Group of Cardiovascular Research
search

1. Study Identification

Unique Protocol Identification Number
NCT04738344
Brief Title
Very Long Versus Overlapping Stents in Long Coronary Lesions
Official Title
The Use of Very Long Versus Overlapping Drug Eluting Stents for the Management of Long Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No enough patients enrolled
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Young Investigator Group of Cardiovascular Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Chronic Coronary Syndrome, Drug Eluting Stents
Keywords
IVUS, Drug Eluting Stents, Chronic Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous coronary intervention and stent implantation using one long stent
Arm Type
Experimental
Arm Description
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
Arm Title
Percutaneous coronary intervention and stent implantation using more than one overlapping stents
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention and Stent Implantation
Other Intervention Name(s)
PCI
Intervention Description
Percutaneous Coronary Intervention and Stent Implantation will be implanted as recommended by guidelines and according to the standard techniques.
Primary Outcome Measure Information:
Title
Coronary angiographic criteria after 6 months of stent deployment
Description
Number of participants with any form in-stent restenosis using control coronary angiography at 6 months
Time Frame
6 months
Title
(IVUS) after 6 months of stent deployment
Description
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
Time Frame
6 months
Title
Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months
Description
Number of patients with any Major Cardiovascular and Cerebrovascular Events (MACCE) at 6 months of stent deployment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Any Major Bleeding Event
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Sobhy, MD
Organizational Affiliation
University of Alexandria - Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amr Zaky, MD
Organizational Affiliation
University of Alexandria - Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed M El Amrawy, MD
Organizational Affiliation
University of Alexandria - Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alexandria
City
Alexandria
ZIP/Postal Code
21321
Country
Egypt
Facility Name
International Cardiac Center (ICC)
City
Alexandria
ZIP/Postal Code
21524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD may be shared with researchers if requested

Learn more about this trial

Very Long Versus Overlapping Stents in Long Coronary Lesions

We'll reach out to this number within 24 hrs