NCT03401216

StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation

StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation: Prospective sTudy Using optIcal cOhereNce Tomography

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI.

Detailed description

Patients with stable, unstable angina and non-ST-elevation ACS will be included in this study. Patient will undergo coronary angiography for coronary anatomy assessment and estimation indications for PCI . After screening an OCT-guided PCI with extra long SYNERGY stent implantation will be provided in all patients. Patient will be divided into 2 groups of follow-up and will be followed within 3 and 6 month after procedure. Final clinical follow-up will be assessed at 12 month for all patients. At each follow-up visits the data regarding clinical events, coronary angiography and OCT-imaging will be collected.

Conditions

• Ischemic Heart Disease
• Coronary Artery Disease
• Coronary Atherosclerosis

Interventions

Type	Name	Description
DEVICE	SYNERGY 48 mm	Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA)
PROCEDURE	PCI	Standard PCI procedure
PROCEDURE	3 month OCT follow-up	Optical coherence tomography imaging of target vessel within 3 month after PCI
PROCEDURE	6 month OCT follow-up	Optical coherence tomography imaging of target vessel within 5 month after PCI

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-04-30
• Completion: 2019-04-30
• First posted: 2018-01-17
• Last updated: 2018-01-17

Locations

1 site across 1 country: Russia