NCT04185285

Brief Summary

The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university Fribourg.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2015Sep 2027

Study Start

First participant enrolled

May 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

November 14, 2019

Last Update Submit

October 14, 2021

Conditions

Coronary Artery DiseasePercutaneous Coronary Intervention

Keywords

PCI

Outcome Measures

Primary Outcomes (6)

  • Patient-oriented composite endpoints (POCE)

    Academic Research Consortium definition

    2 years

  • Major Bleeding

    Bleeding Academic Research Consortium definition

    2 years

  • Patient-oriented composite endpoints (POCE)

    Academic Research Consortium definition

    5 years

  • Major Bleeding

    Bleeding Academic Research Consortium definition

    5 years

  • Patient-oriented composite endpoints (POCE)

    Academic Research Consortium definition

    10 years

  • Major Bleeding

    Bleeding Academic Research Consortium definition

    10 years

Secondary Outcomes (3)

  • all-cause death

    2 years

  • any revascularization

    2 years

  • any myocardial infarction

    2 years

Interventions

Percutaneous coronary intervention, stentsDEVICE

Eligibility Criteria

Age17 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All comers

You may qualify if:

  • All consecutive patients treated by percutaneous coronary intervention at our institution
  • Able to give informed consent and willing to participate

You may not qualify if:

  • Unwillingness to participate
  • Enable to provide inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology, university Fribourg Medical Center

Fribourg, 1708, Switzerland

RECRUITING

Related Publications (1)

  • Cook ST, Allemann L, Cook M, Arroyo DA, Pittet T, Meier P, Togni M, Brahim-Mathiron A, Puricel S, Cook S. Sex differences in ST-segment elevation myocardial infarction patients treated by primary percutaneous intervention. Open Heart. 2025 Jan 4;12(1):e002831. doi: 10.1136/openhrt-2024-002831.

    PMID: 39756819DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary InterventionStents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, cardiology

Study Record Dates

First Submitted

November 14, 2019

First Posted

December 4, 2019

Study Start

May 1, 2015

Primary Completion

September 1, 2017

Study Completion (Estimated)

September 1, 2027

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)