Optical Coherence Tomography for EVERolimus Eluting STent

NCT01146080 | Completed Phase 3 DMC

• 1 other identifier: BG-001-09
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Compared with bare metal stents (BMS), both paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) significantly reduce angiographic restenosis and the need for repeat revascularization in coronary arteries across a broad range of patient and lesion types. However the increased risk of very late stent thrombosis represents a major concern for patients treated with both PES and SES. Optical coherence tomography (OCT), a new imaging technique based on the back reflection of near infrared light, enables real-time, full tomographic, in-vivo visualization of coronary vessel microstructure. Struts coverage and vessel response of drug eluting stent (DES) compared to BMS are the most immediate clinical applications of OCT. Thickness of coverage and strut apposition can be quantified at micron-scale level with a resolution 10-30 times higher than conventional intravascular ultrasound (IVUS). The objective of this study OCTEVEREST (Optical Coherence Tomography for EVERolimus Eluting STent) is to evaluate the long term struts coverage and vessel wall response (abnormal intraluminal defects, strut malapposition, vessel expansions) to the PROMUS™ Everolimus Eluting Stent compared to PROMUS ELEMENT™ Everolimus Eluting Stent implanted for the treatment of stenosis in native coronaries. To investigate the completeness of struts coverage as well as the proportion of malapposed struts and the neointima characteristics, high resolution (\~ 10 µ axial) intracoronary Optical Coherence Tomography (OCT) and intravascular coronary ultrasound (IVUS) will be used.

Conditions

Coronary Artery Disease

Keywords

drug eluting stent; everolimus eluting stent; optical coherence tomography; intravascular ultrasound

Outcome Measures

Primary Outcomes (1)

• Proportion of stent struts uncovered at 6 months as measured by OCT

  The proportion of stent struts uncovered by endothelial tissue will be determined by measuring the number of exposed struts, defined as a measured neointimal hyperplasia (NIH) thickness less than 10 μm, at 0.5 mm cross section analysis, divided by the total number of stent struts. This analysis shall be performed using a dedicated software, as assessed by OCT core lab at 6 month follow up.

  6 months

Secondary Outcomes (6)

• Major Adverse Cardiac Events (MACE)

  1,6,12,24 months

• Stent Thrombosis rate through 24 months

  24 months

• Target Lesion Revascularization

  24 months

• QCA parameters:

  6 months

• Additional OCT parameters

  6 months

Study Arms (2)

Promus Element

EXPERIMENTAL

21 consecutive patients with Promus Element implanted to treat coronary artery lesion

Device: Promus Element

Promus

ACTIVE COMPARATOR

21 consecutive patients with Promus stent implanted to treat coronary artery lesions

Device: Promus

Interventions

Promus Element DEVICE

Promus Element implanted to treat coronary artery lesions.

Promus Element

Promus DEVICE

Promus stent implanted to treat coronary artery lesions

Promus

Eligibility Criteria

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

You may qualify if:

• Patient is ≥ 18 years of age
• Patient is eligible for percutaneous coronary intervention (PCI)
• Patient has documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
• Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 40% as measured prior to enrollment
• Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
• Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.50 mm and ≤ 3,75 mm.
• Target lesion length must measure (by visual estimate) ≤ 24 mm.
• Target lesion must be in a major coronary artery or branch with visually estimated stenosis ≥ 50% and \<100% with TIMI flow \>1.

You may not qualify if:

• The patient has a life expectancy of less than 24 months due to another medical condition
• Patient has a history of hypersensitivity to everolimus or paclitaxel or structurally related compounds
• Patient exhibits cardiogenic shock (systolic pressure \< 80mm Hg and PCWP \> 20mm Hg or cardiac index \<1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure\>80 mm Hg) for any time within 24 hours prior to index procedure
• Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine \> 2.0 mg/dl or 177 μmol/l)
• Planned cardiac surgery procedure ≤ 6 months post-index procedure
• Patient demonstrates evidence of a acute myocardial infarction (eg. STEMI or enzyme elevation CK \> 2X local laboratory's ULN unless CK-MB is \< 2X ULN) 7)
• Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
• Patient demonstrates evidence of leukopenia (leukocyte count \< 3.5 X 109/liter)
• Patient demonstrates evidence of thrombocytopenia (platelet count \< 100,000/mm3) or thrombocytosis (\>750,000/mm3)
• Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
• Patient has been treated with paclitaxel, everolimus or other chemotherapeutic agents within 12-months prior to planned index procedure
• Anticipated treatment with paclitaxel, everolimus or oral rapamycin during any period in the 6-months after the index procedure
• Known allergy to stainless steel
• Female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
• Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure

Sponsors & Collaborators

• A.O. Ospedale Papa Giovanni XXIII: lead
• Case Western Reserve University: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Cardiovascular Department Ospedali Riuniti di Bergamo

Bergamo, BG, 24128, Italy

Location

Related Publications (1)

• Guagliumi G, Capodanno D, Ikejima H, Bezerra HG, Sirbu V, Musumeci G, Fiocca L, Lortkipanidze N, Vassileva A, Tahara S, Valsecchi O, Costa MA. Impact of different stent alloys on human vascular response to everolimus-eluting stent: an optical coherence tomography study: the OCTEVEREST. Catheter Cardiovasc Interv. 2013 Feb;81(3):510-8. doi: 10.1002/ccd.24374. Epub 2012 May 2.

  PMID: 22431208 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Giulio Guagliumi, MD

  Cardiovascular Department Ospedali Riuniti di Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

IT (1)