Acute Stroke With Large Vessel OcclusionDST-TANDEMNCT03588780
Stent Thrombosis After Tandem Lesions Thrombectomy
An observational study of Acute Stroke With Large Vessel Occlusion, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke With Large Vessel Occlusion
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2018to Oct 2018
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
Who may be able to join
- Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
- Association of extracranial internal carotid artery (ICA) occlusion or stenosis ≥70% using NASCET criteria and an intracranial arterial occlusion in the anterior circulation
Who cannot join
- Endovascular treatments for complication of surgical carotid endarterectomy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Neuroradiologie Interventionnelle
Strasbourg, 67098
Rémy BEAUJEUX, MD, PhD, 33 3 88 12 78 71, remy.beaujeux@chru-strasbourg.fr
Raoul POP, MD, 33 3 88 12 78 71, raoul.pop@chru-strasbourg.fr
About this study
Official title: PREDICTEURS ET IMPACT CLINIQUE DE LA THROMBOSE DU STENT APRES LES THROMBECTOMIES CEREBRALES POUR LES OCCLUSIONS EN TANDEM
The aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis
- Conditions
- Acute Stroke With Large Vessel Occlusion
- Keywords
- acute stroke, thrombectomy, tandem lesions
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent thrombosis rate
Measured: participants will be followed for the duration of hospital stay, an expected average 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start6 Aug 2018
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stroke With Large Vessel OcclusionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémy BEAUJEUX, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588780
- Sponsor's protocol ID
- 7167
- Acronym
- DST-TANDEM
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2018
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICTEURS ET IMPACT CLINIQUE DE LA THROMBOSE DU STENT APRES LES THROMBECTOMIES CEREBRALES POUR LES OCCLUSIONS EN TANDEM
- ClinicalTrials.gov ID
- NCT03588780
- Acronym / sponsor ID
- DST-TANDEM / 7167
- Conditions
- Acute Stroke With Large Vessel Occlusion
- Keywords
- acute stroke, thrombectomy, tandem lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 17 Jul 2018 (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 is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
Key inclusion criteria (2 listed)
- Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
- Association of extracranial internal carotid artery (ICA) occlusion or stenosis ≥70% using NASCET criteria and an intracranial arterial occlusion in the anterior circulation
Key exclusion criteria (1 listed)
- Endovascular treatments for complication of surgical carotid endarterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stent thrombosis rate
Time frame: participants will be followed for the duration of hospital stay, an expected average 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
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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.
Rémy BEAUJEUX, MD, PhD study director
University Hospital, Strasbourg, France
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 Acute Stroke With Large Vessel Occlusion, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rémy BEAUJEUX, MD, PhD (33 3 88 12 78 71, remy.beaujeux@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent thrombosis rate (time frame: participants will be followed for the duration of hospital stay, an expected average 15 days). 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 21 Sep 2018.