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

Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Stable Angina; Unstable Angina; NSTEMI
• Intervention / Treatment: Device: Amphilimus Eluting Stent; Device: Bare Metal Stent

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • FE
    • Ferrara, FE, Italy, 44121
      • Azienda Ospedaliero - Universitaria S.Anna
  • RM
    • Roma, RM, Italy, 00168
      • Policlinico Universitario "Agostino Gemelli"
    • Roma, RM, Italy, 00184
      • Azienda Ospedaliera S. Giovanni - Addolorata
  • TO
    • Torino, TO, Italy, 10128
      • Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"
  • VI
    • Bassano del Grappa, VI, Italy, 36061
      • ULSS n°3 - Ospedale Civile
• Netherlands
  • Utrecht, Netherlands
    • University Medical Centre Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
• Target lesion located in the left main stem;
• Ostial lesion location;
• Target lesion has TIMI 0 flow;
• Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CRE8 arm	Device: Amphilimus Eluting Stent; Sirolimus formulated coronary eluting stent
ACTIVE_COMPARATOR: Vision/Multilik8 arm	Device: Bare Metal Stent; Bare metal coronary stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss	immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Clinical composite endpoints	Cardiac death/Target vessel MI/Clinically indicated TLR; All death/All MI/All TVR (including TLR)	At 1, 3 and 12 months
Stent Thrombosis		during index procedure, immediately after index procedure, 1 month, 3 months, 12 months

Collaborators and Investigators

• Sponsor: CID - Carbostent & Implantable Devices
• Investigators: Principal Investigator: Francesco Prati, MD, Ospedale S. Giovanni - Addolorata

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (ESTIMATE): March 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Coronary artery disease; Optical Coherence Tomography; DES; Tissue coverage
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: C21101