NCT05584280

Brief Summary

To conduct a quality assurance project to establish the differences in health care processes and cost effectiveness of having the thin-strut Orsiro stent versus the thicker strut Promus stent on the shelf (i.e. as the most accessible stent).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,067

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

May 29, 2026

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 13, 2022

Last Update Submit

May 28, 2026

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • Cost effectiveness ratio (percent)

    Cost effectiveness of Orsiro compared to Promus on shelf.

    1 year

Secondary Outcomes (5)

  • How long time did the procedure take?

    During the procedure

  • How many other stents were used?

    During the procedure

  • How many additional units were needed?

    During the procedure

  • How many patients were treated?

    1 week

  • Composite of all-cause death, myocardial infarction, or coronary revascularization

    1- year

Study Arms (2)

Promus stent on shelf

Control

Device: Promus stent on shelf

Orsiro stent on shelf

Treatment

Device: Orsiro stent on shelf

Interventions

Orsiro stent on shelfDEVICE

Cluster randomization to Orsiro stent on shelf vs. control

Orsiro stent on shelf
Promus stent on shelfDEVICE

Cluster randomization to Promus stent on shelf vs. treatment

Promus stent on shelf

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing PCI at any hospital participating in the study

You may qualify if:

  • Patients undergoing PCI at any hospital participating in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kardiologen

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 18, 2022

Study Start

December 6, 2022

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

May 29, 2026

Record last verified: 2022-10

Locations

SE(1)