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Trial record 1 of 7 for:    inspiron
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Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent (Inspiron RL II)

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.
 
ClinicalTrials.gov Identifier: NCT03263260
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

Study Description
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Brief Summary:
Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.

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

Detailed Description:

Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.

Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure.

Patients will be followed at 30 days, 1 and 2 years after procedure.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Groups and Cohorts
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Group/Cohort Intervention/treatment
implanted patients
Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent
 Device: implant
coronary stent implantation


Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Cardiac Events Rate [ Time Frame: 12 months ]
    Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis


Secondary Outcome Measures :
  1. Target Vessel and Lesion Revascularization Rates [ Time Frame: 24 months ]
    Target Vessel and Lesion Revascularization

  2. Stent Thrombosis Rate [ Time Frame: 24 months ]
    Stent Thrombosis


Eligibility Criteria
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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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries
Criteria

Inclusion Criteria:

  • alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years

Exclusion Criteria:

  • Safein Vein or Left Internal Mammary artery Grafts
Contacts and Locations
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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): NCT03263260


Locations
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Brazil
União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS
Porto Alegre, Rio Grande Do Sul, Brazil, 90.619-900
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
More Information
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Additional Information:

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Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT03263260    
Other Study ID Numbers: Inspiron RL II
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: April 2023
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Scitech Produtos Medicos Ltda:
stent, DES, Inspiron
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases