Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2022-12-07
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Promus stent on shelf
Control
Promus stent on shelf
Cluster randomization to Promus stent on shelf vs. treatment
Orsiro stent on shelf
Treatment
Orsiro stent on shelf
Cluster randomization to Orsiro stent on shelf vs. control
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Locations
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Kardiologen
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPECS - 01
Identifier Type: -
Identifier Source: org_study_id
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