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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03263260|
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: implant|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|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|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2022|
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
coronary stent implantation
- Major Adverse Cardiac Events Rate [ Time Frame: 12 months ]Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis
- Target Vessel and Lesion Revascularization Rates [ Time Frame: 24 months ]Target Vessel and Lesion Revascularization
- Stent Thrombosis Rate [ Time Frame: 24 months ]Stent Thrombosis
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
|Contact: Erico Rossi||+55 62 3625-5000|
|União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90.619-900|
|Contact: Paulo Caramori, Medicine email@example.com|
|Principal Investigator: Paulo Caramori, Medicine|