Inspiron RL II: Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

Sponsor

Scitech Produtos Medicos Ltda (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03263260

Collaborator

(none)

5,000

Enrollment

Location

90.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Other

Time Perspective:

Prospective

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 :

Jun 2, 2017

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Major Adverse Cardiac Events Rate [12 months]
Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis

Secondary Outcome Measures

Target Vessel and Lesion Revascularization Rates [24 months]
Target Vessel and Lesion Revascularization
Stent Thrombosis Rate [24 months]
Stent Thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scitech Produtos Medicos Ltda

ClinicalTrials.gov Identifier:

NCT03263260

Other Study ID Numbers:

Inspiron RL II

First Posted:

Aug 28, 2017

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Scitech Produtos Medicos Ltda

stent, DES, Inspiron

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of May 10, 2022