Coronary Artery DiseaseNCT04738344
Very Long Versus Overlapping Stents in Long Coronary Lesions
A study testing Percutaneous Coronary Intervention and Stent Implantation in people with Coronary Artery Disease and Chronic Coronary Syndrome, run by The Young Investigator Group of Cardiovascular Research at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chronic Coronary Syndrome, Drug Eluting Stents
- What is being tested?
- Percutaneous Coronary Intervention and Stent Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Single vessel disease and undergoing PCI for significant long lesion.
- Chronic stable angina on maximal medical treatment.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
University of Alexandria
Alexandria, 21321
International Cardiac Center (ICC)
Alexandria, 21524
About this study
Official title: 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.
Read the 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.
- Being tested
- Percutaneous Coronary Intervention and Stent Implantation
- Keywords
- IVUS, Drug Eluting Stents, Chronic Coronary Syndrome
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention and Stent ImplantationDevice
Also called PCI
Percutaneous Coronary Intervention and Stent Implantation will be implanted as recommended by guidelines and according to the standard techniques.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Percutaneous Coronary Intervention and Stent Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: No enough patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Young Investigator Group of Cardiovascular Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mohamed A Sobhy, MD, Study chair, University of Alexandria - EgyptAmr Zaky, MD, Study director, University of Alexandria - EgyptAhmed M El Amrawy, MD, Principal investigator, University of Alexandria - Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738344
- Sponsor's protocol ID
- YIG0122001
- Status last verified
- Oct 2022
- First submitted
- 20 Dec 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be shared with researchers if requested
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Very Long Versus Overlapping Drug Eluting Stents for the Management of Long Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT04738344
- Acronym / sponsor ID
- YIG0122001
- Keywords
- IVUS, Drug Eluting Stents, Chronic Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enough patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Young Investigator Group of Cardiovascular ResearchResearch network
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention and stent implantation using one long stent | Experimental | Device: Percutaneous Coronary Intervention and Stent ImplantationLong 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 |
| Percutaneous coronary intervention and stent implantation using more than one overlapping stents | Experimental | Device: Percutaneous Coronary Intervention and Stent ImplantationLong 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Single vessel disease and undergoing PCI for significant long lesion.
- Chronic stable angina on maximal medical treatment.
Key exclusion criteria (8 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Intervention and Stent ImplantationAlso: PCIPercutaneous Coronary Intervention and Stent Implantation will be implanted as recommended by guidelines and according to the standard techniques. | Device | Percutaneous coronary intervention and stent implantation using more than one overlapping stents, Percutaneous coronary intervention and stent implantation using one long stent |
Primary outcome
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
(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
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
1 secondary outcome
Any Major Bleeding Event
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No. IPD may be shared with researchers if requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Sobhy, MD study chair
University of Alexandria - Egypt
Amr Zaky, MD study director
University of Alexandria - Egypt
Ahmed M El Amrawy, MD principal investigator
University of Alexandria - Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention and Stent Implantation in people with Coronary Artery Disease and Chronic Coronary Syndrome, run by The Young Investigator Group of Cardiovascular Research at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary angiographic criteria after 6 months of stent deployment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.