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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03401216
• Other study ID #: Exeption
• Status: Recruiting
• Phase: N/A
• First received: December 25, 2017
• Last updated: January 15, 2018
• Start date: March 20, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: January 2018
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Aleksei Prokhorikhin, MD
• Phone: +79137178040
• Email: turbogold[@]list.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent before study procedures

• Subject is eligible for percutaneous coronary intervention (PCI)

• Left ventricular ejection fraction (LVEF) >30%

• Reference vessel diameter (RVD) =2.25 mm and =4.0 mm

• Target lesion(s) length must be =38 mm

• Target lesion(s) stenosis =50%

Exclusion Criteria:

• History of acute or recent stroke (<2 months)

• Contraindications for antiplatelet and/or anticoagulant therapy

• Bleeding within the last 30 days

• Subject has acute ST elevation MI (STEMI)

• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support

• Subject with out of range complete blood count (CBC) values determined as a clinically significant

• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis

• Subject has baseline serum creatinine level >2.0 mg/dL (177µmol/L)

• Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure

• Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

• Lesion located within a saphenous vein graft or an arterial graft

• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)

• Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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
• 3 month OCT follow-up
Optical coherence tomography imaging of target vessel within 3 month after PCI
• 6 month OCT follow-up
Optical coherence tomography imaging of target vessel within 5 month after PCI

Locations

Country	Name	City	State
Russian Federation	Academician E.N. Meshalkin national medical research center	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Boston Scientific Corporation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Target lesion failure (TLF)	TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.	12 month after PCI
Other	Cardiac death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	12 month after PCI
Other	Myocardial infarction	Type 1, 2, 3, 4a, 4b according to Third Universal Definition of Myocardial Infarction	12 month after PCI
Other	Stent thrombosis	Definite and probable, according to ARC definition,	12 month after PCI
Primary	Neointimal healing score	The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level: Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4".; Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of "3"; Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"; Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1"	within 3 month after PCI
Primary	Neointimal healing score	The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level: Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4".; Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of "3"; Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"; Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1"	within 6 month after PCI
Secondary	Percentage of strut coverage assessed by OCT	In metallic DES, the struts are classified as covered in the presence of a coverage thickness >0 µm (tissue can be identified above the struts).	within 3 month after PCI
Secondary	Percentage of strut coverage assessed by OCT	In metallic DES, the struts are classified as covered in the presence of a coverage thickness >0 µm (tissue can be identified above the struts).	within 6 month after PCI
Secondary	Percentage of mature neointimal tissue assessed by OCT	To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.	within 3 month after PCI
Secondary	Percentage of mature neointimal tissue assessed by OCT	To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.	within 6 month after PCI