Systematic Post-Implementation Evaluation of Stents (SPECS)

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).

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Device: Promus stent on shelf; Device: Orsiro stent on shelf

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 6000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Björn Redfors, MD, PhD; Phone Number: 7543 +46313421000; Email: bjorn.redfors@wlab.gu.se
• Study Contact Backup: Name: Oskar Angerås, MD, PhD; Phone Number: +46313421000; Email: oskar.angeras@vgregion.se

Study Locations

• Sweden
  • Göteborg, Sweden, 41345
    • Recruiting
    • Kardiologen
    • Contact: Björn Redfors, MD, PhD; Phone Number: 0313427543; Email: bjoern.redfors@wlab.gu.se
    • Contact: Elmir Omerovic, MD, Prof; Phone Number: 0704560787; Email: elmir@wlab.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI at any hospital participating in the study

Description

Inclusion Criteria:

• Patients undergoing PCI at any hospital participating in the study

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Promus stent on shelf; Control	Device: Promus stent on shelf; Cluster randomization to Promus stent on shelf vs. treatment
Orsiro stent on shelf; Treatment	Device: Orsiro stent on shelf; Cluster randomization to Orsiro stent on shelf vs. control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness ratio (percent)	Cost effectiveness of Orsiro compared to Promus on shelf.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How long time did the procedure take?	Procedure time (continuous variable)	During the procedure
How many additional units were needed?	Number of adjunct devices used	During the procedure
How many patients were treated?	Number of patients treated	1 week
Composite of all-cause death, myocardial infarction, or coronary revascularization	Cumulative risk of death, myocardial infarction, or coronary revascularization	1- year
How many other stents were used?	Proportion of other stents used (percent)	During the procedure

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: SPECS - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No