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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by CID - Carbostent & Implantable Devices.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier:
NCT01543373
First received: February 20, 2012
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Stable Angina
Unstable Angina
NSTEMI
Device: Amphilimus Eluting Stent
Device: Bare Metal Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation

Resource links provided by NLM:


Further study details as provided by CID - Carbostent & Implantable Devices:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    1 month for the BMS arm; 3 months for the DES arm


Secondary Outcome Measures:
  • Percentage of malapposed stent struts [ Time Frame: Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm) ] [ Designated as safety issue: Yes ]
  • Percentage of malapposed and uncovered stent struts [ Time Frame: 1 month (BMS arm) / 3 months (DES arm) ] [ Designated as safety issue: Yes ]
  • Neointimal growth and neointimal thickness [ Time Frame: 1 month (BMS arm) / 3 months (DES arm) ] [ Designated as safety issue: No ]
  • Angiographic in-stent and in-segment endpoints [ Time Frame: immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm) ] [ Designated as safety issue: No ]
    reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss

  • Clinical composite endpoints [ Time Frame: At 1, 3 and 12 months ] [ Designated as safety issue: Yes ]
    • Cardiac death/Target vessel MI/Clinically indicated TLR
    • All death/All MI/All TVR (including TLR)

  • Stent Thrombosis [ Time Frame: during index procedure, immediately after index procedure, 1 month, 3 months, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543373

Contacts
Contact: Cristina Isaia 0039-0161-1826291 cristina.isaia@cidvascular.com

Locations
Italy
Azienda Ospedaliero - Universitaria S.Anna Recruiting
Ferrara, FE, Italy, 44121
Principal Investigator: Marco Valgimigli, MD, PhD         
Azienda Ospedaliera S. Giovanni - Addolorata Recruiting
Roma, RM, Italy, 00184
Principal Investigator: Francesco Prati, MD         
Policlinico Universitario "Agostino Gemelli" Recruiting
Roma, RM, Italy, 00168
Principal Investigator: Francesco Burzotta, MD, PhD         
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         
Netherlands
University Medical Centre Utrecht Not yet recruiting
Utrecht, Netherlands
Principal Investigator: Pieter Stella, MD, PhD         
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
Investigators
Principal Investigator: Francesco Prati, MD Ospedale S. Giovanni - Addolorata
  More Information

No publications provided

Responsible Party: CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier: NCT01543373     History of Changes
Other Study ID Numbers: C21101
Study First Received: February 20, 2012
Last Updated: February 27, 2012
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 22, 2014