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CRE8 in All Comers Patients

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: NCT01687075
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : June 28, 2016
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
The purpose of the study is to evaluate clinical performances of Cre8 in all comer population in Subjects over 18 years old who are undergoing a clinically indicated coronary angiogram and angioplasty on de-novo lesion located in native coronary arteries

Condition or disease Intervention/treatment Phase
Consecutive Subjects Who Are Suitable for a Coronary Angioplasty of de Novo Lesion(s) in Native Coronary Arteries Should be Screened for Eligibility. A Total Number of 200 Patients Fulfilling the Selection Criteria and Willing to Sign the Informed Consent Should be Enrolled in the Trial. Device: CR8 a drug eluting coronary stent Not Applicable

Detailed Description:

The development, clinical validation, and widespread use of drug-eluting stents have revolutionized the treatment of patients with coronary artery disease. Large scale, prospective, multicenter double-blind randomized trials have provided strong evidence that sirolimus-eluting stents, paclitaxel-eluting stents, and zotarolimus-eluting stents significantly reduce angiographic restenosis and enhance event-free survival compared with bare-metal stents after implantation in native coronary arteries1. However, higher rates of late and very late stent thrombosis with SES and PES, likely due to delayed and incomplete endothelialization compared with BMS, have raised safety concerns with DES as a class. Therefore, alongside clinical investigations, histopathological evaluations were conducted on the coronary arteries of patients who died after DES implantation to examine the healing status of the vessel. The evidence obtained suggested that the polymer components used to carry the drug in the first generation of DES may be associated with a local inflammatory response, associated with localized hypersensitivity and eosinophil infiltration, with consequent alteration of the vessel wall and delay in the formation of the endothelium. Because specific stent design and/or polymer features may impact DES performance, numerous studies have focused on the comparative assessment of various DES, with conflicting results.

The clinical need thus exists for enhanced stent designs which offer improved safety and efficacy profiles compared to the earlier stent platforms.

new technologies have been developed which have led to the creation of devices with delivery systems based on the use of more biocompatible or bioabsorbable polymers and cytostatic drugs similar to sirolimus. The clinical data obtained with this second generation have demonstrated, in all devices tested, no less efficacy than first-generation DES, and a better safety profile, although not statistically significant.Concerning the most widely used second generation DES,after a small first-in-man trial, its safety and efficacy was further studied in larger randomized trials on patients with non-complex lesions in which EES was compared to PES, proving its angiographic superiority and clinical non-inferiority. A step forward, in assessing the clinically significant differences among different DES, was done with a new randomized trial comparing EES versus PES, powered for testing superiority in clinical outcomes and of sufficient magnitude to provide data on patient subgroups, particularly patients with diabetes. At present, a third-generation of DES, developed to minimize the possible side effects related to the presence of the polymer, is being evaluated in humans. To avoid the presence of the polymer on the surface of the device, different platforms are being evaluated: those with a porous surface onto which the pure drug is placed and those with holes closed towards the intraluminal part by a bioabsorbable polymer, onto which the drug is loaded. A third option to avoid the need of polymers has been used in the new CRE8 DES, featuring a polymer free platform with abluminal reservoirs to release the Amphilimus formulation. This device has been tested against Taxus Liberté in a randomized clinical trial, to assess the non-inferiority angiographic efficacy results. The 6month angiographic analysis, demonstrates that the primary study endpoint has been achieved, showing that CRE8 was not inferior to Taxus Liberté in terms of efficacy performances.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRE8 in All Comers Patients
Study Start Date : October 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: CR8
a drug eluting coronary device, made of Cobalt-Chromium alloy and integrally coated with i-Carbofilm™, loaded with formulated Sirolimus
Device: CR8 a drug eluting coronary stent
a drug eluting coronary device, made of Cobalt-Chromium alloy and integrally coated with i-Carbofilm™, loaded with formulated Sirolimus

Primary Outcome Measures :
  1. Incidence of 6-month device-oriented clinical composite endpoint, defined as Cardiac death / Target vessel MI / Clinically indicated TLR [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of clinical composite endpoints at 30 days, 1 year from the index procedure [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18 years
  • Patients with symptoms of stable angina or documented silent ischemia
  • Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score
  • Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI
  • Patient is eligible for percutaneous coronary intervention and is an acceptable candidate for surgical revascularization
  • Left ventricular ejection fraction > 30%;
  • Target de-novo lesions with diameter stenosis > 50% (including total occlusion)
  • Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm;
  • 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;
  • Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
  • Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis);
  • Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder;
  • Known significant gastro-intestinal or urinary bleeding within the past 6 months;
  • Patient refusing blood transfusion;
  • Patient currently under immunosuppressant therapy;
  • Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  • 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, within 3 months prior to the index procedure;
  • Target lesion is located or supplied by an arterial or venous bypass graft

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): NCT01687075

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Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64329
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Shmuel Banai, Prof Tel Aviv Medical Center
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Responsible Party: michal roll, Prof. Shmuel Banai, Tel-Aviv Sourasky Medical Center Identifier: NCT01687075    
Other Study ID Numbers: Create
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
coronary angioplasty
de novo lesion