Very Long Versus Overlapping Stents in Long Coronary Lesions

NCT04738344 | Withdrawn

• 1 other identifier: YIG0122001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Chronic Coronary Syndrome; Drug Eluting Stents

Keywords

IVUS; Drug Eluting Stents; Chronic Coronary Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Any Major Bleeding Event

  6 months

Study Arms (2)

Percutaneous coronary intervention and stent implantation using one long stent

EXPERIMENTAL

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 using more than one overlapping stents

EXPERIMENTAL

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

Interventions

Percutaneous Coronary Intervention and Stent Implantation DEVICE

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

Also known as: PCI

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Single vessel disease and undergoing PCI for significant long lesion.
• Chronic stable angina on maximal medical treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Young Investigator Group of Cardiovascular Research: lead

Study Sites (2)

University of Alexandria

Alexandria, 21321, Egypt

Location

International Cardiac Center (ICC)

Alexandria, 21524, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mohamed A Sobhy, MD

  University of Alexandria - Egypt

  STUDY CHAIR

• Amr Zaky, MD

  University of Alexandria - Egypt

  STUDY DIRECTOR

• Ahmed M El Amrawy, MD

  University of Alexandria - Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: February 4, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)