Clinical trial NCT04738344: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Chronic Coronary Syndrome
Drug Eluting Stents
Keywords: IVUS
Drug Eluting Stents
Chronic Coronary Syndrome
Lead sponsor: The Young Investigator Group of Cardiovascular Research
Sponsor class: NETWORK
First posted: 2021-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Coronary angiographic criteria after 6 months of stent deployment
timeFrame: 6 months
measure: (IVUS) after 6 months of stent deployment
timeFrame: 6 months
measure: Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Any Major Bleeding Event
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: University of Alexandria
city: Alexandria
country: Egypt
facility: International Cardiac Center (ICC)
Study officials:
affiliation: University of Alexandria - Egypt
name: Mohamed A Sobhy, MD
role: STUDY_CHAIR
affiliation: University of Alexandria - Egypt
name: Amr Zaky, MD
role: STUDY_DIRECTOR
affiliation: University of Alexandria - Egypt
name: Ahmed M El Amrawy, MD
role: PRINCIPAL_INVESTIGATOR
References: