Coronary Artery DiseaseSTABONCT05023629
STunning After Balloon Occlusion
A study testing Intracoronary balloon inflation in people with Coronary Artery Disease, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The aim of this study is to examine in-depth cardiac function and morphology after short-term coronary occlusion by balloon inflation in patients with stable coronary artery disease (CAD) who undergo percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intracoronary balloon inflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 6 Sep 2021to 1 Jan 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Stable CAD with indication for PCI of a lesion in either of the following coronary segments:
- 6 or 7 (proximal or mid left anterior descending coronary artery)
- 11 (Proximal left circumflex coronary artery)
- 1 or 2 (proximal right coronary artery)
- Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography.
- Written informed consent obtained.
Who cannot join
- Pre-existing heart failure
- Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel.
- Severe valvulopathy
- Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the target vessel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STunning After Balloon Occlusion, A Single-center, Single-arm, Prospective Study
The aim of this study is to examine in-depth cardiac function and morphology after short-term coronary occlusion by balloon inflation in patients with stable coronary artery disease (CAD) who undergo percutaneous coronary intervention (PCI).
Read the detailed description
Primary objectives:
- To determine the time-course for the resolution of regional myocardial function after short-term coronary artery occlusion in patients with stable CAD who undergo PCI. Secondary objectives:
- To confirm by cardiac magnetic resonance imaging that no myocardial injury occurs after short-term coronary occlusion in patients who undergo PCI due to stable CAD.
- To establish a clinical model for studying myocardial stunning.
- Conditions
- Coronary Artery Disease
- Being tested
- Intracoronary balloon inflation
- Keywords
- Percutaneous Coronary Intervention, Myocardial stunning
- Medical subject headings
- Coronary Artery Disease, Myocardial Stunning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary balloon inflationOther
Patients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a significant coronary artery lesion | Other | Balloon inflation for 90s Receives: Other: Intracoronary balloon inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precent Akinesia
Time until recovery of percent akinesia (percent Akinesia; defined as more than 80 percent recovery compared to percent Akinesia at 30 minutes post balloon occlusion).
Measured: 30 minutes post balloon occlusion
Secondary outcomes (9)
Difference in percent Akinesia
Difference in percent Akinesia at 30 minutes compared to baseline (before balloon occlusion).
Measured: 30 minutes
Difference in radial myocardial Strain
Difference in radial myocardial Strain (in percent) in the myocardial segments subtended by the target vessel at 30 minutes compared to baseline measured with speckle tracking.
Measured: 30 minutes
Time until recovery of radial Strain
Time until recovery of radial Strain in the myocardial segments subtended by the target vessel (defined more than 80 percent recovery compared to 30 minutes post balloon occlusion)
Measured: 30 minutes
Percent Akinesia
Percent Akinesia in the myocardial segments
Measured: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Radial myocardial Strain
Radial myocardial Strain (in percent) in the myocardial segments subtended by the target vessel measured with speckle tracking.
Measured: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Global longitudinal Strain
Global longitudinal Strain (in percent) in the heart measured with speckle tracking.
Measured: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Myocardial wall motion index
Myocardial wall motion index
Measured: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular ejection fraction
Left ventricular ejection fraction
Measured: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular stroke volume index
Left ventricular stroke volume index
Measured: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start6 Sep 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Hard to find patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center, single-arm, prospective study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Björn Redfors, Principal investigator, Sahlgrenska Universitetssjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023629
- Sponsor's protocol ID
- v.2.0
- Acronym
- STABO
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to GDPR regulation
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STunning After Balloon Occlusion, A Single-center, Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT05023629
- Acronym / sponsor ID
- STABO / v.2.0
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Myocardial stunning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Hard to find patient
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 26 Aug 2021 (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.
The aim of this study is to examine in-depth cardiac function and morphology after short-term coronary occlusion by balloon inflation in patients with stable coronary artery disease (CAD) who undergo percutaneous coronary intervention (PCI).
Detailed description
Primary objectives:
- To determine the time-course for the resolution of regional myocardial function after short-term coronary artery occlusion in patients with stable CAD who undergo PCI. Secondary objectives:
- To confirm by cardiac magnetic resonance imaging that no myocardial injury occurs after short-term coronary occlusion in patients who undergo PCI due to stable CAD.
- To establish a clinical model for studying myocardial stunning.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center, single-arm, prospective study
| Arm | Type | Receives |
|---|---|---|
| Patients with a significant coronary artery lesion | Other | Other: Intracoronary balloon inflationBalloon inflation for 90s |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years.
- Stable CAD with indication for PCI of a lesion in either of the following coronary segments:
- Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography.
- Written informed consent obtained.
Key exclusion criteria (4 listed)
- Pre-existing heart failure
- Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel.
- Severe valvulopathy
- Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the target vessel.
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 |
|---|---|---|
| Intracoronary balloon inflationPatients with a significant coronary artery lesion in a proximal coronary segment will undergo intracoronary balloon inflation for 90s prior to PCI. | Other | Patients with a significant coronary artery lesion |
Primary outcome
Precent Akinesia
Time frame: 30 minutes post balloon occlusion
Time until recovery of percent akinesia (percent Akinesia; defined as more than 80 percent recovery compared to percent Akinesia at 30 minutes post balloon occlusion).
9 secondary outcomes
Difference in percent Akinesia
Time frame: 30 minutes
Difference in radial myocardial Strain
Time frame: 30 minutes
Time until recovery of radial Strain
Time frame: 30 minutes
Percent Akinesia
Time frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Radial myocardial Strain
Time frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Global longitudinal Strain
Time frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Myocardial wall motion index
Time frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular ejection fraction
Time frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Left ventricular stroke volume index
Time frame: 1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours
Results and safety
The study was stopped early (reason given: Hard to find patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Due to GDPR regulation
Related trials for Coronary Artery Disease
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Not yet recruiting
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
Coronary Artery Disease (CAD)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
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.
Björn Redfors principal investigator
Sahlgrenska Universitetssjukhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracoronary balloon inflation in people with Coronary Artery Disease, 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Jun 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 was stopped early (reason given: Hard to find patient). Results are not available in the source record.
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?
Precent Akinesia (time frame: 30 minutes post balloon occlusion). 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 2 Jun 2026.