Systematic Post-Implementation Evaluation of Stents

Myocardial Ischemia Clinical Trial

— SPECS  

Official title:

Systematic Post-Implementation Evaluation of Stents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584280
• Other study ID #: SPECS - 01
• Status: Recruiting
• Start date: December 7, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2022
• Source: Vastra Gotaland Region
• Contact: Björn Redfors, MD, PhD
• Phone: +46313421000
• Email: bjorn.redfors[@]wlab.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Background:

Individual patient-level randomized trials have suggested that the ultrathin strut Orsiro stent is associated with a lower risk of adverse ischemic events than the thin strut Promus stent. However, there are theoretical advantages of each stent in regards to usability, delivery and radial strength.

Study design:

The SPECS trial is a prospective, open-label, cross-sectional, cluster randomized quality assurance project, in which cardiac catheterization laboratories (hereafter referred to as center) in Västra Götaland Sweden will participate. Each week each center will place either Orsiro or Promus in the shelf in the cath lab as the most accessible stent (their workhorse stent). The specific stent to be placed on the shelf at each center each week will be randomly decided.

All patients will be treated according to local treatment guidelines and at the discretion of the interventional cardiologists, including the choice of stents.

The patients will be identified via the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. The events at will be identified and extracted from Patient registry (Socialstyrelsen), Population registry (Folkbokföringen), Causes of death registry (Socialstyrelsen). Stent usage will be monitored via SWEDEHEART and local databases (stents for which the package was opened but the stent discarded).

Study population:

Patients undergoing percutaneous coronary intervention (PCI) in Västra Götaland.

Primary objectives:

To investigate the cost-effectivess of placing either thin or thick strut stents on the shelf in the cath lab.

To investigate the weekly costs associated with placing either thin or thick strut stents on the shelf in the cath lab.

All outcomes will be tracked over time to assess whether greater experience with the thin strut stents results in changes in any cost differences over time.

If a sufficient number of patients are treated over the course of the project, retrospective analyses may be conducted using the assigned shelf stent as an instrument for assessing the effect of thin vs. thick stents on outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing PCI at any hospital participating in the study

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Orsiro stent on shelf
Cluster randomization to Orsiro stent on shelf vs. control
• Promus stent on shelf
Cluster randomization to Promus stent on shelf vs. treatment

Locations

Country	Name	City	State
Sweden	Kardiologen	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost effectiveness ratio (percent)	Cost effectiveness of Orsiro compared to Promus on shelf.	1 year
Secondary	How long time did the procedure take?	Procedure time (continuous variable)	During the procedure
Secondary	How many other stents were used?	Proportion of other stents used (percent)	During the procedure
Secondary	How many additional units were needed?	Number of adjunct devices used	During the procedure
Secondary	How many patients were treated?	Number of patients treated	1 week
Secondary	Composite of all-cause death, myocardial infarction, or coronary revascularization	Cumulative risk of death, myocardial infarction, or coronary revascularization	1- year