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Trial record 15 of 76 for:    Long-chain fatty acids

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

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ClinicalTrials.gov Identifier: NCT02360709
Recruitment Status : Recruiting
First Posted : February 11, 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 system in the treatment of patients with de novo coronary artery lesions.

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

Detailed Description:
This is a prospective, multi-center, single-arm observational registry trial planned to enroll 800 subjects. All 800 subjects enrolled will receive CRE8 stents. Clinical follow-up will be performed at 1 month, 6 months,12 months and annually up to 5 years after the procedure.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective, Multi-center, Single-arm Observational Registry Trial Evaluating the Safety and Efficacy of CRE8 Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions
Study Start Date : November 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Group/Cohort Intervention/treatment
CRE8 group
CRE8 sirolimus-eluting stent
Device: CRE8 sirolimus-eluting stent
The CRE8 stent system consists of a sirolimus eluting coronary stent firmly held on the distal end of a semicompliant balloon catheter. This stent is made of cobalt chromium alloy and is coated with a thin carbon film.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.




Primary Outcome Measures :
  1. Target lesion failure (TLF,device-oriented endpoint) [ Time Frame: 12months after the procedure ]

Secondary Outcome Measures :
  1. Target lesion failure (TLF,device-oriented endpoint) [ Time Frame: 1month,6months,2years,3years,4years and 5years follow-up ]
  2. The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations [ Time Frame: 1month,6months,12months and annually up to 5years follow-up ]
  3. Stent thrombosis per ARC definition [ Time Frame: 1month,6months,12months and annually up to 5years follow-up ]
  4. device and lesion success rates [ Time Frame: immidiately after the procedure ]
  5. clinical success rate [ Time Frame: 7 days after the procedure ]


Information from the National Library of Medicine

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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
Sampling Method:   Non-Probability Sample
Study Population
This trial plans to enroll 800 subjects with de novo coronary artery lesions. Patients with reference diameter between 2.25mm and 4.5 mm (by visual estimation) and lesion length not more than 60mm (by visual estimation) will be enrolled.
Criteria

Inclusion Criteria:

  • 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;
  • Target vessel diameter between 2.25mm and 4.5 mm, and target lesion length ≤ 60mm by visual estimation;
  • Target lesion diameter stenosis ≥ 70% by visual estimation;
  • Each target lesion must be implanted the same stent (CRE8);
  • 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 consents.

Exclusion Criteria:

  • Patients with acute myocardial infarction (AMI) within 72 hours;
  • Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment;
  • 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 lesions;
  • 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, 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): NCT02360709


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

Additional Information:

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Responsible Party: CID S.p.A.
ClinicalTrials.gov Identifier: NCT02360709     History of Changes
Other Study ID Numbers: CRE8-China-SA
First Posted: February 11, 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