StrokeASTRO-TAVINCT05241821
Acute STROke Complicating TAVI - Management and Outcomes
An observational study of Stroke and Aortic Valve Stenosis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Stroke, Aortic Valve Stenosis, Periprocedural Complication
- What is being tested?
- Mechanical thrombectomy and Thrombolytic Agent
- Type of treatment
- Surgery or procedure
- How many people
- 484 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2021to 5 Feb 2022
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with periprocedural stroke complicating TAVI
Who may be able to join
- patients who have had a stroke within 30 days of TAVI
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.
- Conditions
- Stroke, Aortic Valve Stenosis, Periprocedural Complication
- Being tested
- Mechanical thrombectomy, Thrombolytic Agent
- Keywords
- periprocedural stroke, transcatheter aortic valve implantation, transcatheter aortic valve replacement
- Medical subject headings
- Stroke, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.
Thrombolytic AgentDrug
Drug aimed to dissolve thrombus affecting the cerebral circulation
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | patients with periprocedural stroke after TAVI, treated conservatively | |
| Neuro-intervention | patients with periprocedural stroke after TAVI, treated with neuro-intervention Receives: Procedure: Mechanical thrombectomy; Drug: Thrombolytic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All cause death
Measured: 1-year
Neurologic disability free survival
modified rankin score (mRS) 0/1
Measured: 90 days
Secondary outcomes (1)
Bleeding complications
Severe bleeding / life-threatening bleeding as defined by VARC2 criteria
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Jun 2021
- Primary completion31 Jan 2022
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Retrospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amos Levi, Rabin Medical Center
- Investigators
- Ran Kornowski, MD, Principal investigator, Head of cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241821
- Sponsor's protocol ID
- 0502-21
- Acronym
- ASTRO-TAVI
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05241821
- Acronym / sponsor ID
- ASTRO-TAVI / 0502-21
- Conditions
- Stroke, Aortic Valve Stenosis, Periprocedural Complication
- Keywords
- periprocedural stroke, transcatheter aortic valve implantation, transcatheter aortic valve replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 16 Feb 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.
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | – | –patients with periprocedural stroke after TAVI, treated conservatively |
| Neuro-intervention | – | Procedure: Mechanical thrombectomy, Drug: Thrombolytic Agentpatients with periprocedural stroke after TAVI, treated with neuro-intervention |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with periprocedural stroke complicating TAVI
Key inclusion criteria (1 listed)
- patients who have had a stroke within 30 days of TAVI
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 |
|---|---|---|
| Mechanical thrombectomyPercutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation. | Procedure or surgery | Neuro-intervention |
| Thrombolytic AgentDrug aimed to dissolve thrombus affecting the cerebral circulation | Drug | Neuro-intervention |
Primary outcome
All cause mortality
Time frame: 1-year
All cause death
Neurologic disability free survival
Time frame: 90 days
modified rankin score (mRS) 0/1
1 secondary outcome
Bleeding complications
Time frame: 30 days
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 16 Feb 2022.
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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.
Ran Kornowski, MD principal investigator
Head of cardiology
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 Stroke and Aortic Valve Stenosis, run by Rabin Medical Center at 1 site in Israel.
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 16 Feb 2022. 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 Israel. 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?
All cause mortality (time frame: 1-year). The study lists 2 primary outcomes in all. 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 16 Feb 2022.