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

April 27, 2018 updated by: CID - Carbostent & Implantable Devices

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT
Time Frame: within 3 months from index procedure
1 month for the BMS arm; 3 months for the DES arm
within 3 months from index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of malapposed stent struts
Time Frame: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Percentage of malapposed and uncovered stent struts
Time Frame: 1 month (BMS arm) / 3 months (DES arm)
1 month (BMS arm) / 3 months (DES arm)
Neointimal growth and neointimal thickness
Time Frame: 1 month (BMS arm) / 3 months (DES arm)
1 month (BMS arm) / 3 months (DES arm)
Angiographic in-stent and in-segment endpoints
Time Frame: immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
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
Time Frame: At 1, 3 and 12 months
  • Cardiac death/Target vessel MI/Clinically indicated TLR
  • All death/All MI/All TVR (including TLR)
At 1, 3 and 12 months
Stent Thrombosis
Time Frame: during index procedure, immediately after index procedure, 1 month, 3 months, 12 months
during index procedure, immediately after index procedure, 1 month, 3 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CID - Carbostent & Implantable Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francesco Prati, MD, Ospedale S. Giovanni - Addolorata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C21101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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