Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

NCT01543373 | Completed

• 1 other identifier: C21101
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.

Conditions

Stable Angina; Unstable Angina; NSTEMI

Keywords

Coronary artery disease; Optical Coherence Tomography; Tissue coverage; DES

Outcome Measures

Primary Outcomes (1)

• Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT

  1 month for the BMS arm; 3 months for the DES arm

  within 3 months from index procedure

Secondary Outcomes (6)

• Percentage of malapposed stent struts

  Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)

• Percentage of malapposed and uncovered stent struts

  1 month (BMS arm) / 3 months (DES arm)

• Neointimal growth and neointimal thickness

  1 month (BMS arm) / 3 months (DES arm)

• Angiographic in-stent and in-segment endpoints

  immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)

• Clinical composite endpoints

  At 1, 3 and 12 months

Study Arms (2)

CRE8 arm

EXPERIMENTAL

Device: Amphilimus Eluting Stent

Vision/Multilik8 arm

ACTIVE COMPARATOR

Device: Bare Metal Stent

Interventions

Amphilimus Eluting Stent DEVICE

Sirolimus formulated coronary eluting stent

CRE8 arm

Bare Metal Stent DEVICE

Bare metal coronary stent

Vision/Multilik8 arm

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years;
• Patients with symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
• Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
• Left ventricular ejection fraction \> 30%;
• Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement;
• Target de-novo lesion;
• Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm;
• Target lesion diameter stenosis \> 50% and \< 100% by visual estimate, with a TIMI flow of \>=1;
• Discrete lesion with a length ranging from 13 to 25 mm;
• The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (Cre8 or Vision/Multilink 8), according to the randomization arm;
• Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

You may not qualify if:

• Female with childbearing potential or lactating;
• Patient presenting with acute myocardial infarction with ST elevation;
• Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
• Cerebrovascular accident within the past 6 months;
• Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
• Thrombocytopenia (platelet count less than 100,000/mm³);
• Known bleeding or hypercoagulable disorder;
• Currently under immunosuppressant therapy;
• Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
• Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
• Patient underwent target vessel revascularization with a DES;
• Heavily calcified vessel and/or lesion which cannot be successfully predilated or imaged by OCT
• Target lesion is located or supplied by an arterial or venous bypass graft;
• Lesion located very distally, difficult to be imaged by OCT;
• Lesion located in angulated (\>70°), sharp take-off vessel;

Sponsors & Collaborators

• CID - Carbostent & Implantable Devices: lead

Study Sites (6)

Azienda Ospedaliero - Universitaria S.Anna

Ferrara, FE, 44121, Italy

Location

Policlinico Universitario "Agostino Gemelli"

Roma, RM, 00168, Italy

Location

Azienda Ospedaliera S. Giovanni - Addolorata

Roma, RM, 00184, Italy

Location

Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"

Torino, TO, 10128, Italy

Location

ULSS n°3 - Ospedale Civile

Bassano del Grappa, VI, 36061, Italy

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Francesco Prati, MD

  Ospedale S. Giovanni - Addolorata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 5, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

IT (5); NL (1)