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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01543373
Recruitment Status : Unknown
Verified February 2012 by CID - Carbostent & Implantable Devices.
Recruitment status was:  Recruiting
First Posted : March 5, 2012
Last Update Posted : March 5, 2012
Information provided by (Responsible Party):
CID - Carbostent & Implantable Devices

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.

Condition or disease Intervention/treatment Phase
Stable Angina Unstable Angina NSTEMI Device: Amphilimus Eluting Stent Device: Bare Metal Stent Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation
Study Start Date : January 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : June 2013

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Percentage of malapposed stent struts [ Time Frame: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm) ]
  2. Percentage of malapposed and uncovered stent struts [ Time Frame: 1 month (BMS arm) / 3 months (DES arm) ]
  3. Neointimal growth and neointimal thickness [ Time Frame: 1 month (BMS arm) / 3 months (DES arm) ]
  4. 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

  5. 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)

  6. Stent Thrombosis [ Time Frame: during index procedure, immediately after index procedure, 1 month, 3 months, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01543373

Contact: Cristina Isaia 0039-0161-1826291

Azienda Ospedaliero - Universitaria S.Anna Recruiting
Ferrara, FE, Italy, 44121
Principal Investigator: Marco Valgimigli, MD, PhD         
Policlinico Universitario "Agostino Gemelli" Recruiting
Roma, RM, Italy, 00168
Principal Investigator: Francesco Burzotta, MD, PhD         
Azienda Ospedaliera S. Giovanni - Addolorata Recruiting
Roma, RM, Italy, 00184
Principal Investigator: Francesco Prati, MD         
Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino" Not yet recruiting
Torino, TO, Italy, 10128
Principal Investigator: Mauro De Benedictis, MD         
ULSS n°3 - Ospedale Civile Recruiting
Bassano del Grappa, VI, Italy, 36061
Principal Investigator: Angelo Ramondo, MD         
University Medical Centre Utrecht Not yet recruiting
Utrecht, Netherlands
Principal Investigator: Pieter Stella, MD, PhD         
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
Principal Investigator: Francesco Prati, MD Ospedale S. Giovanni - Addolorata

Responsible Party: CID - Carbostent & Implantable Devices Identifier: NCT01543373     History of Changes
Other Study ID Numbers: C21101
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: February 2012

Keywords provided by CID - Carbostent & Implantable Devices:
Coronary artery disease
Optical Coherence Tomography
Tissue coverage

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Angina, Unstable
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms