Product Surveillance Registry

Coronary Artery Disease Clinical Trial

— PSR  

Official title:

Medtronic Product Surveillance Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524276
• Other study ID #: PSR
• Status: Recruiting
• Start date: January 2012
• Est. completion date: January 2030

Study information

• Verified date: March 2024
• Source: Medtronic
• Contact: Medtronic Product Surveillance Registry
• Email: rs.productsurveillanceregistry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has or is intended to receive or be treated with an eligible Medtronic product
• Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

• Patient who is, or will be, inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Related Conditions & MeSH terms

• Aneurysm
• Aortic, Peripheral Vascular and Venous Disorders
• Arrhythmias, Cardiac
• Cardiac Rhythm Disorders
• Cardiovascular Diseases
• Cardiovascular Disorders
• Coronary Artery Disease
• Diagnostic Techniques and Procedures
• Digestive Disorders
• Digestive System Diseases
• Intracranial Aneurysm
• Mechanical Circulatory Support
• Minimally Invasive Surgical Procedures
• Nervous System Diseases
• Neurological Disorders
• Renal Insufficiency
• Respiratory Therapy
• Surgical Procedures, Operative
• Urologic Diseases
• Urological Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Kuwait,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Serbia,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Effectiveness of Market Released products		Every 6-12 months (Therapy-dependent)