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Trial record 21 of 76 for:    Long-chain fatty acids

Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions

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ClinicalTrials.gov Identifier: NCT02360423
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
CID S.p.A.

Brief Summary:
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: CRE8 sirolimus-eluting stent Device: RESOLUTE zotarolimus-eluting stent Phase 3

Detailed Description:
This study consists of a randomized controlled cohort and a long stent observational cohort. The randomized controlled trial is a prospective, multi-center, non-inferior, randomized controlled trial. The control device (RESOLUTE zotarolimus-eluting stent) used in this trial was provided by Medtronic. RESOLUTE zotarolimus-eluting stent has been already approved by China Food and Drug Administration (CFDA) in 2009 and become commercially available in Chinese market. 400 patients enrolled in this trial will be randomly assigned to CRE8 group (n=200) and RESOLUTE group (n=200) in a 1:1 ratio. The long stent observational trial plans to enroll 30 consecutive patients. Patients in the observational cohort will receive the long CRE8 stent with length 38mm.All 430 patients will be required to receive clinical follow-up at 1 month, 6 months, 9 months, 12 months and annually up to 5 years after the procedure, and angiographic follow-up at 9 months after the procedure. The primary endpoint is in-stent LLL at 9 months after the procedure, and the secondary endpoints are device success rate, device-oriented cardiovascular composite endpoint, patient-oriented cardiovascular composite endpoint and stent thrombosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent Versus the RESOLUTE Zotarolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions
Study Start Date : November 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: CRE8 group
CRE8 sirolimus-eluting stent system
Device: CRE8 sirolimus-eluting stent
The CRE8 stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.

Active Comparator: RESOLUTE group
RESOLUTE zotarolimus-eluting stent system
Device: RESOLUTE zotarolimus-eluting stent
The RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market




Primary Outcome Measures :
  1. In-stent late lumen loss (LLL) [ Time Frame: 9months after the procedure ]

Secondary Outcome Measures :
  1. In-stent, proximal stent edge, distal stent edge and In-segment binary restenosis rate [ Time Frame: 9months after the procedure ]
  2. In-segment late lumen loss (LLL) [ Time Frame: 9months after the procedure ]
  3. Target lesion failure (TLF) rate [ Time Frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up ]
  4. Number of participants with stent thrombosis per ARC definition [ Time Frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up ]
  5. The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations [ Time Frame: 1month, 6months, 9months, 12months and annually up to 5 years follow-up ]
  6. device and lesion success rates [ Time Frame: immediately after the procedure ]
  7. clinical success rate [ Time Frame: 7 days after the procedure ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria for randomized cohort:

  • Age ≥18 years and ≤ 75 years, male or female without pregnancy;
  • Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
  • De novo lesions of native coronary arteries (lesions number ≤ 2);
  • Target vessel diameter between 2.25 and 4.0 mm and target lesion length ≤ 27mm by visual estimation;
  • Target lesion diameter stenosis ≥ 70% by visual estimation;
  • Each target lesion is permitted to implant only one stent at most, except bailout stent;
  • Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
  • Patients with left ventricular ejection fraction ≥40%;
  • Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent.

Inclusion criteria for the long stent observational cohort:

  • Age ≥18 years and ≤ 75 years, male or female without pregnancy;
  • Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
  • De novo lesions of native coronary arteries (lesions number ≤ 2);
  • Target lesion diameter stenosis ≥ 70% by visual estimation;
  • At least one target lesion with reference vessel diameter between 2.5mm and 4.0mm and requires 38mm stent exists;
  • Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
  • Patients with left ventricular ejection fraction ≥40%;
  • Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent.

Exclusion Criteria:

  • Patients with acute myocardial infarction (AMI) within one week;
  • Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
  • Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
  • In-stent restenosis;
  • Thrombotic lesion;
  • Patients who had received any other stent in the past one year;
  • Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
  • Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
  • Patients who allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, zotarolimus, polymer, Co-Cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor;
  • Patients with life expectancy less than 1year;
  • Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
  • Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol;
  • Patients who had underwent heart transplant surgery.

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 ClinicalTrials.gov identifier (NCT number): NCT02360423


Contacts
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Contact: Shubin Qiao, MD +86 13701237893 qli@ccrfmed.com;qsbfw@sina.com

Locations
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China, Beijing
Fuwai Hospital,National Center for Cardiovasular disease Recruiting
Beijing, Beijing, China, 100044
Contact: Shubin Qiao, MD    +86 13701237893    qsbfw@sina.com   
Sponsors and Collaborators
CID S.p.A.
Investigators
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Principal Investigator: Shubin Qiao, MD Fu Wai Hospital, National Center for Cardiovasular disease

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Responsible Party: CID S.p.A.
ClinicalTrials.gov Identifier: NCT02360423     History of Changes
Other Study ID Numbers: CRE8-China-RCT
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs