Myocardial IschemiaSPECSNCT05584280
Systematic Post-Implementation Evaluation of Stents
An observational study of Myocardial Ischemia, run by Vastra Gotaland Region at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Orsiro stent on shelf and Promus stent on shelf
- Type of treatment
- Medical device
- How many people
- 1,067 participants
- Where
- 1 siteSweden
- Study dates
- 6 Dec 2022to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing PCI at any hospital participating in the study
Who may be able to join
- Patients undergoing PCI at any hospital participating in the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Orsiro stent on shelf, Promus stent on shelf
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orsiro stent on shelfDevice
Cluster randomization to Orsiro stent on shelf vs. control
Promus stent on shelfDevice
Cluster randomization to Promus stent on shelf vs. treatment
| Study group | Role | What they receive |
|---|---|---|
| Promus stent on shelf | Control Receives: Device: Promus stent on shelf | |
| Orsiro stent on shelf | Treatment Receives: Device: Orsiro stent on shelf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost effectiveness ratio (percent)
Cost effectiveness of Orsiro compared to Promus on shelf.
Measured: 1 year
Secondary outcomes (5)
How long time did the procedure take?
Procedure time (continuous variable)
Measured: During the procedure
How many other stents were used?
Proportion of other stents used (percent)
Measured: During the procedure
How many additional units were needed?
Number of adjunct devices used
Measured: During the procedure
How many patients were treated?
Number of patients treated
Measured: 1 week
Composite of all-cause death, myocardial infarction, or coronary revascularization
Cumulative risk of death, myocardial infarction, or coronary revascularization
Measured: 1- year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start6 Dec 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584280
- Sponsor's protocol ID
- SPECS - 01
- Acronym
- SPECS
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Post-Implementation Evaluation of Stents
- ClinicalTrials.gov ID
- NCT05584280
- Acronym / sponsor ID
- SPECS / SPECS - 01
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promus stent on shelf | – | Device: Promus stent on shelfControl |
| Orsiro stent on shelf | – | Device: Orsiro stent on shelfTreatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing PCI at any hospital participating in the study
Key inclusion criteria (1 listed)
- Patients undergoing PCI at any hospital participating in the study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orsiro stent on shelfCluster randomization to Orsiro stent on shelf vs. control | Device | Orsiro stent on shelf |
| Promus stent on shelfCluster randomization to Promus stent on shelf vs. treatment | Device | Promus stent on shelf |
Primary outcome
Cost effectiveness ratio (percent)
Time frame: 1 year
Cost effectiveness of Orsiro compared to Promus on shelf.
5 secondary outcomes
How long time did the procedure take?
Time frame: During the procedure
How many other stents were used?
Time frame: During the procedure
How many additional units were needed?
Time frame: During the procedure
How many patients were treated?
Time frame: 1 week
Composite of all-cause death, myocardial infarction, or coronary revascularization
Time frame: 1- year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost effectiveness ratio (percent) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.