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DRUG ELUTING STENT FOR DIABETIC PATIENTS IN CORONARY ARTERY DISEASE TREATMENT (DEDICATE)

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ClinicalTrials.gov Identifier: NCT03509532
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
IRCCS Policlinico S. Donato
Information provided by (Responsible Party):
Luca Testa, IRCCS Policlinico S. Donato

Brief Summary:

Study Title A post market registry of Abluminus® sirolimus eluting coronary stent system for percutaneous intervention in patients with diabetes mellitus Purpose The purpose of this registry is to prospectively capture clinical data of ABLUMINUS® sirolimus eluting stent in patients with Diabetes Mellitus.

Investigational Device ABLUMINUS® sirolimus eluting stent consists of four components; a bare metal stent (BMS), a delivery system, the bio absorbable polymer delivery matrix and Abluminal surface coating on stent and parts of balloon in Pre-crimped condition the anti-proliferative drug, Sirolimus.

Study Design Prospective, Observational, Multi-center registry Estimated Enrolment 1000 patients

End points Primary Endpoints:

Target Lesion Failure that is composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months.

Components of the primary end point are defined as follows:

  • Cardiac Death: any death due to immediate cardiac cause, deaths related to the procedure, unwitnessed death, and death of unknown cause.
  • Target Vessel Myocardial infarction: categorised according to the Minnesota electrocardiographic criteria (Q-wave and non-Q-wave). Spontaneous myocardial infarction was defined as a typical rise and fall of creatinine kinase-MB fraction or troponin in the presence of at least one of several conditions: ischaemic symptoms, new pathological Q waves, ischaemic electrocardiographic changes, or pathological evidence of acute myocardial infarction. Peri-procedural myocardial infarction was defined as an increase in creatinine kinase to more than twice the normal value with increased values of confirmatory biomarkers (creatinine kinase-MB fraction or troponin higher than usual). Target-vessel-related myocardial infarction was one related to the target vessel or that could not be clearly related to another vessel.
  • Target Lesion Revascularisation: any repeat percutaneous or surgical intervention due to a stenosis or occlusion within the device of the index procedure.

Secondary Endpoints

  • Stent thrombosis [Time Frame: 1 month, 12 months, yearly]. Definite and probable stent thrombosis according to ARC definitions;
  • Cardiac death [Time Frame: 1 month, 12 months, yearly]
  • Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly]
  • Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly]
  • Device Success at 24 hours
  • Lesion Success at 24 hours
  • Procedural Success at 24 hours Eligibility Eligible Age: 18 Years and older. Eligible Genders: Both. Inclusion Criteria
  • The patient must be at least 18 years of age.
  • Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered).
  • The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery.
  • Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);
  • Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU;
  • Patient provides written informed consent;
  • Patient agrees to all required follow-up procedures and visits. Exclusion Criteria • The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer.
  • Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis.
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study.
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
  • Previous coronary intervention on target vessel.
  • Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Lesions not allowing a complete balloon inflation or stent deployment. Clinical Follow up At Discharge, 1 month, 6 months, 12 months, yearly.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: PCI

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A POST MARKET REGISTRY OF ABLUMINUS® SIROLIMUS ELUTING CORONARY STENT SYSTEM FOR PERCUTANEOUS INTERVENTION IN PATIENTS WITH DIABETES MELLITUS
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: PCI
    PCI


Primary Outcome Measures :
  1. MACE [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients with coronary artery disease
Criteria

Inclusion Criteria:

  • The patient must be at least 18 years of age.
  • Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered).
  • The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery.
  • Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);
  • Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU;
  • Patient provides written informed consent;
  • Patient agrees to all required follow-up procedures and visits.

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer.
  • Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis.
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study.
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
  • Previous coronary intervention on target vessel.
  • Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Lesions not allowing a complete balloon inflation or stent 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 ClinicalTrials.gov identifier (NCT number): NCT03509532


Locations
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Italy
IRCCS Pol. San Donato Recruiting
Milan, Italy, 20090
Contact: Luca Testa, MD, PhD    +39-3490808660    luctes@gmail.com   
Principal Investigator: Francesco Bedogni, MD         
Sponsors and Collaborators
Istituto Clinico Sant'Ambrogio
IRCCS Policlinico S. Donato
Additional Information:

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Responsible Party: Luca Testa, MD; PhD, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03509532    
Other Study ID Numbers: DEDICATE
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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