Carotid Artery StenosisNCT05195658
Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)
An observational study of Carotid Artery Stenosis and Acute Ischemic Stroke, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial summary
Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Acute Ischemic Stroke
- What is being tested?
- Thrombectomy and Stenting under neuroprotection
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jan 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All-comers clinical registry of consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, cleared for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines.
Who may be able to join
- Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis/occlusion as culprit lesion.
- Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.
- Patient eligible for endovascular stroke therapy according to AHA/ASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.
- Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center)
- Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated.
Who cannot join
- Known stroke cause other than the carotid bifurcation lesion
- Lack of effective endovascular route needed for intervention
- Any known contraindications to stroke endovascular management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, 31-202
Piotr Musialek, MD, DPhil, +48126142287, pmusialek@szpitaljp2.krakow.pl
About this study
Official title: Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF The MicronEt-covered CGUARD STent Under TRansient FlOw Reversal LinKed With Thrombus REtrieval: SAFEGUARD-STROKE Study
Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use.
A study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window allowing guideline-indicated reperfusion by interventional management.
A registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.
Read the detailed description
Acute stroke of carotid artery bifurcation origin presents a major treatment challenge. With the large volume of affected brain tissue, this stroke type -if left untreated- has an extremely unfavorable prognosis. With a typical large thrombus load in the extracranial carotid artery, the efficacy of systemic intravenous thrombolysis - the mainstay of ischemic stroke treatment- is very poor (reported recanalization rates <5%). With a high risk of complications (including cerebral embolism) and poor clinical outcomes, patients with acute stroke of carotid artery bifurcation origin (≈20-30% large-vessel occlusion strokes) are underrepresented in stroke mechanical reperfusion trials that have typically not included such patients.
No contemporary clinical studies have been dedicated specifically to management acute stroke of carotid artery bifurcation origin. In contrast to cerebral artery occlusion, in which the treatment algorithm is well-established, in the stroke of carotid artery bifurcation origin neither the reperfusion window nor the optimal revascularization method are yet determined. This results in a low level of evidence regarding the choice of a particular treatment method - endovascular emergent mechanical revascularization or surgical. Carotid surgery in acute major stroke setting is particularly challenging. Also, the surgical treatment modality is unable to address the problem of acute embolus in the large intracerebral vessel(s) that co-exists in about one in every three patients with acute stroke of carotid bifurcation origin.
With regard to minimally-invasive endovascular treatment, one fundamental limitation of the carotid stents used so far to address the culprit lesion (single-layer, first-generation stents) has been their inability to adequately sequestrate (insulate) the atherothrombotic lesion, resulting in an increased risk of new cerebral embolism and enhancing the risk of stent acute occlusion. Circumstantial evidence suggests that the Micronet-covered stent (in particular in combination with 'proximal' cerebral protection and, whenever indicated and feasible, in combination with aspiration or stentriever thrombectomy) may increase both safety and efficacy of carotid revascularization in acute stroke of carotid bifurcation origin.
A novel dual-layered Micronet-covered stent system (CGuard) has been demonstrated to markedly reduce peri- (and eliminate post-) procedural cerebral embolism in elective carotid artery stenting (Level 1 evidence) but has not yet been systematically tested in the emergent setting. This prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin eligible for endovascular interventional management will evaluate the use of Micronet-covered Stent (CGuard) to seal the stroke culprit lesion and reconstruct the lumen of the artery supplying the brain. Proximal cerebral protection (by transient flow reversal using a balloon guide catheter such as the MoMa or FlowGate) is used whenever feasible. In addition, extra/intra-cranial thrombus retrieval will be performed as clinically indicated, using either the aspiration technique and/or a stentriever.
Eligibility for study treatment is based on the decision (recommendation) of a multidisciplinary NeuroVascular Team Committee, consisting of a cardioangiologist certified in stroke mechanical thrombectomy or an interventional (neuro)radiologist, stroke neurologist and anesthesiologist. Use of pharmacologic agents and intended devices is according to international guidelines and instructions for use.
The study involves evaluation of clinical and cerebrovascular imaging data (presentation, outcome) in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window (salvageable cerebral tissue, small cerebral infarct core/large penumbra) allowing guideline-indicated reperfusion by interventional management. Cerebral and vascular non-invasive imaging will involve computed tomography and/or magnetic resonance imaging modalities as clinically indicated.
The study is a registry of consecutive patients with the study condition, treated using the device of interest. This is an open-label study, without randomization - a single arm, single-center study.
- Conditions
- Carotid Artery Stenosis, Acute Ischemic Stroke
- Being tested
- Thrombectomy and Stenting under neuroprotection
- Keywords
- Carotid Stenosis, Acute Ischemic Stroke, Anesthesia, Imaging, Interventional Management, Thrombectomy
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombectomy and Stenting under neuroprotectionDevice
Endovascular management of the stroke culprit lesion using the Micronet-covered CGuard stent under neuroprotection.
Transient flow achieved using a balloon guide catheter (e.g. MoMa or FlowGate) with additional active aspiration/s at key procedural steps. If indicated, targeted (extra- and/or intracranial) thrombus retrieval using either a thrombus aspiration device and/or a stentriever.
Use of pharmaco-sedation versus general anesthesia is as indicated clinically and is according to the anesthesiologist and operator decision - according to routine practice in the center.
Patient pre-procedural (including imaging and other diagnostic work-up), procedural, and post-procedural (including blood pressure tight control) management, including pharmacotherapy, are according to the AHA/ASA stroke management guidelines and the devices IFUs. Overall study patient management and intervention is according to routine clinical practice in the study center.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke with culprit lesion at the carotid bifurcation | Consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, accepted for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines Receives: Device: Thrombectomy and Stenting under neuroprotection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from poor clinical status at 90 days
Freedom from poor clinical status (expressed as modified Rankin score, mRS >2) at 90 days
Measured: 90 days from index procedure
Secondary outcomes (21)
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
Freedom from any death, any new stroke (ischemic or hemorrhagic, including hemorrhagic transformation of index stroke), and myocardial infarction at 30-day follow-up
Measured: At 30 days from index procedure
Freedom from major clinical complications comprising MACNE at 90 days
Freedom from any death, any new stroke (ischemic or hemorrhagic, including hemorrhagic transformation of index stroke), and myocardial infarction at 90-day follow-up
Measured: At 90 days from index procedure
Freedom from major clinical complications comprising MACNE at 12 months
Freedom from any death, any new stroke (ischemic or hemorrhagic, including hemorrhagic transformation of index stroke), and myocardial infarction at 12-months follow-up
Measured: At 12 months from index procedure
Procedural success rate for carotid intervention
Rate of patients with success of endovascular treatment of the culprit carotid lesion i.e. procedural success (stent delivery and implantation, withdrawal of stent delivery system, residual stenosis ≤30% of vessel lumen diameter, procedure without complications)
Measured: Periprocedural
Technical success rate for carotid intervention
Number of procedures completed using the study device in relation to the number of attempted procedures
Measured: At procedure completion
Clinical success rate for carotid intervention
Number of procedures completed with a good clinical outcome (mRS 0-2 at 90 days) in relation to the number of attempted procedures
Measured: 90 days after procedure
Rate of successful cerebral recanalization
Rate of patients with index hemisphere optimal cerebral flow post-procedurally (modified TICI 2b or 3)
Measured: At procedure completion
Freedom from embolism to the new territory during procedure
Freedom from embolism to the new territory at the post-procedural angiogram
Measured: During index procedure
Rate of peri-procedural cerebral complications
Rate of patients with peri-procedural cerebral complications such as embolism to new territory or symptomatic intracranial haemorrhage (i.e. parenchymal haematoma on imaging with clinical deterioration).
Measured: At procedure completion
Rate of other major periprocedural complications
Rate of patients with other major peri-procedural complications: acute renal failure, systemic infection, respiratory failure requiring prolonged ventilation (>24 hours), vascular access site complication requiring surgery
Measured: Up to 7 days post-procedure
New ipsilateral stroke free survival up to 1 year
Survival without any stroke up to 1 year follow up
Measured: From procedure completion till 1 year post-procedure
New ipsilateral stroke free survival up to 5 year
Survival without any stroke up to 5 year follow up
Measured: From procedure completion till 5 years post-procedure
Carotid restenosis free survival up to 1 year
Survival without carotid restenosis requiring treatment up to 1 year follow up
Measured: From procedure completion till 1 year post-procedure
Carotid restenosis free survival up to 5 years
Survival without carotid restenosis requiring treatment up to 5 year follow up
Measured: From procedure completion till 5 years post-procedure
Rate of carotid reintervention
Rate of patients with clinically indicated reintervention in the index carotid artery during follow up period
Measured: From procedure completion till 5 years post-procedure
Feasibility of combined treatment
Number of patients actually treated with combined treatment (defined as the use of Micronet-covered stent and proximal cerebral protection) to the number of patients with attempted such treatment
Measured: At the procedure completion
NIHSS score change
Change in National Institutes of Health Stroke Scale score between the point of presentation and 90 days.
Measured: At 90 days post procedure
Freedom from stent thrombosis at 30 days
Freedom from clinical or ultrasound stent thrombosis detected within 30 days after procedure
Measured: At 30 days post procedure
Freedom from stent thrombosis at 90 days
Freedom from clinical or ultrasound stent thrombosis detected within 90 days after procedure
Measured: At 90 days post procedure
Freedom from stent thrombosis or in-stent restenosis up to 1 year
Freedom from clinical or ultrasound stent thrombosis or significant in-stent restenosis detected within 12 months after procedure
Measured: At 1 year after procedure
Stent thrombosis or in-stent restenosis up to 5 years
Clinical or ultrasound stent thrombosis or significant in-stent restenosis detected within 5 years after procedure
Measured: At 5 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start30 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Musialek, MD, DPhil, Principal investigator, Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195658
- Sponsor's protocol ID
- SAFEGUARD-STROKE
- Status last verified
- Feb 2022
- First submitted
- 31 Dec 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tekieli L, Afanasjev A, Mazgaj M, Borodetsky V, Sievert K, Ruzsa Z, Knapik M, Sirvinskas A, Mazurek A, Dzierwa K, Sanczuk T, Mosenko V, Urbanczyk-Zawadzka M, Trystula M, Paluszek P, Wiewiorka L, Stefaniak J, Pieniazek P, Slautaite I, Kwiatkowski T, Mackevicius A, Teitcher M, Sievert H, Grunwald IQ, Musialek P. A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE. Postepy Kardiol Interwencyjnej. 2024 Jun;20(2):172-193. doi: 10.5114/aic.2024.140963. Epub 2024 Jun 30.
PubMed 39022700Tekieli L, Dzierwa K, Grunwald IQ, Mazurek A, Urbanczyk-Zawadzka M, Wiewiorka L, Banys RP, Dabrowski W, Podlasek A, Weglarz E, Stefaniak J, Nizankowski RT, Musialek P. Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry. J Cardiovasc Surg (Torino). 2024 Jun;65(3):231-248. doi: 10.23736/S0021-9509.24.13093-5.
PubMed 39007556
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF The MicronEt-covered CGUARD STent Under TRansient FlOw Reversal LinKed With Thrombus REtrieval: SAFEGUARD-STROKE Study
- ClinicalTrials.gov ID
- NCT05195658
- Acronym / sponsor ID
- SAFEGUARD-STROKE
- Conditions
- Carotid Artery Stenosis, Acute Ischemic Stroke
- Keywords
- Carotid Stenosis, Acute Ischemic Stroke, Anesthesia, Imaging, Interventional Management, Thrombectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jan 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.
Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use.
A study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window allowing guideline-indicated reperfusion by interventional management.
A registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.
Detailed description
Acute stroke of carotid artery bifurcation origin presents a major treatment challenge. With the large volume of affected brain tissue, this stroke type -if left untreated- has an extremely unfavorable prognosis. With a typical large thrombus load in the extracranial carotid artery, the efficacy of systemic intravenous thrombolysis - the mainstay of ischemic stroke treatment- is very poor (reported recanalization rates <5%). With a high risk of complications (including cerebral embolism) and poor clinical outcomes, patients with acute stroke of carotid artery bifurcation origin (≈20-30% large-vessel occlusion strokes) are underrepresented in stroke mechanical reperfusion trials that have typically not included such patients.
No contemporary clinical studies have been dedicated specifically to management acute stroke of carotid artery bifurcation origin. In contrast to cerebral artery occlusion, in which the treatment algorithm is well-established, in the stroke of carotid artery bifurcation origin neither the reperfusion window nor the optimal revascularization method are yet determined. This results in a low level of evidence regarding the choice of a particular treatment method - endovascular emergent mechanical revascularization or surgical. Carotid surgery in acute major stroke setting is particularly challenging. Also, the surgical treatment modality is unable to address the problem of acute embolus in the large intracerebral vessel(s) that co-exists in about one in every three patients with acute stroke of carotid bifurcation origin.
With regard to minimally-invasive endovascular treatment, one fundamental limitation of the carotid stents used so far to address the culprit lesion (single-layer, first-generation stents) has been their inability to adequately sequestrate (insulate) the atherothrombotic lesion, resulting in an increased risk of new cerebral embolism and enhancing the risk of stent acute occlusion. Circumstantial evidence suggests that the Micronet-covered stent (in particular in combination with 'proximal' cerebral protection and, whenever indicated and feasible, in combination with aspiration or stentriever thrombectomy) may increase both safety and efficacy of carotid revascularization in acute stroke of carotid bifurcation origin.
A novel dual-layered Micronet-covered stent system (CGuard) has been demonstrated to markedly reduce peri- (and eliminate post-) procedural cerebral embolism in elective carotid artery stenting (Level 1 evidence) but has not yet been systematically tested in the emergent setting. This prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin eligible for endovascular interventional management will evaluate the use of Micronet-covered Stent (CGuard) to seal the stroke culprit lesion and reconstruct the lumen of the artery supplying the brain. Proximal cerebral protection (by transient flow reversal using a balloon guide catheter such as the MoMa or FlowGate) is used whenever feasible. In addition, extra/intra-cranial thrombus retrieval will be performed as clinically indicated, using either the aspiration technique and/or a stentriever.
Eligibility for study treatment is based on the decision (recommendation) of a multidisciplinary NeuroVascular Team Committee, consisting of a cardioangiologist certified in stroke mechanical thrombectomy or an interventional (neuro)radiologist, stroke neurologist and anesthesiologist. Use of pharmacologic agents and intended devices is according to international guidelines and instructions for use.
The study involves evaluation of clinical and cerebrovascular imaging data (presentation, outcome) in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window (salvageable cerebral tissue, small cerebral infarct core/large penumbra) allowing guideline-indicated reperfusion by interventional management. Cerebral and vascular non-invasive imaging will involve computed tomography and/or magnetic resonance imaging modalities as clinically indicated.
The study is a registry of consecutive patients with the study condition, treated using the device of interest. This is an open-label study, without randomization - a single arm, single-center study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke with culprit lesion at the carotid bifurcation | – | Device: Thrombectomy and Stenting under neuroprotectionConsecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, accepted for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers clinical registry of consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, cleared for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines.
Key inclusion criteria (5 listed)
- Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis/occlusion as culprit lesion.
- Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.
- Patient eligible for endovascular stroke therapy according to AHA/ASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.
- Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center)
- Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated.
Key exclusion criteria (3 listed)
- Known stroke cause other than the carotid bifurcation lesion
- Lack of effective endovascular route needed for intervention
- Any known contraindications to stroke endovascular management
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 |
|---|---|---|
| Thrombectomy and Stenting under neuroprotectionEndovascular management of the stroke culprit lesion using the Micronet-covered CGuard stent under neuroprotection. Transient flow achieved using a balloon guide catheter (e.g. MoMa or FlowGate) with additional active aspiration/s at key procedural steps. If indicated, targeted (extra- and/or intracranial) thrombus retrieval using either a thrombus aspiration device and/or a stentriever. Use of pharmaco-sedation versus general anesthesia is as indicated clinically and is according to the anesthesiologist and operator decision - according to routine practice in the center. Patient pre-procedural (including imaging and other diagnostic work-up), procedural, and post-procedural (including blood pressure tight control) management, including pharmacotherapy, are according to the AHA/ASA stroke management guidelines and the devices IFUs. Overall study patient management and intervention is according to routine clinical practice in the study center. | Device | Acute ischemic stroke with culprit lesion at the carotid bifurcation |
Primary outcome
Freedom from poor clinical status at 90 days
Time frame: 90 days from index procedure
Freedom from poor clinical status (expressed as modified Rankin score, mRS >2) at 90 days
21 secondary outcomes
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
Time frame: At 30 days from index procedure
Freedom from major clinical complications comprising MACNE at 90 days
Time frame: At 90 days from index procedure
Freedom from major clinical complications comprising MACNE at 12 months
Time frame: At 12 months from index procedure
Procedural success rate for carotid intervention
Time frame: Periprocedural
Technical success rate for carotid intervention
Time frame: At procedure completion
Clinical success rate for carotid intervention
Time frame: 90 days after procedure
Rate of successful cerebral recanalization
Time frame: At procedure completion
Freedom from embolism to the new territory during procedure
Time frame: During index procedure
Rate of peri-procedural cerebral complications
Time frame: At procedure completion
Rate of other major periprocedural complications
Time frame: Up to 7 days post-procedure
New ipsilateral stroke free survival up to 1 year
Time frame: From procedure completion till 1 year post-procedure
New ipsilateral stroke free survival up to 5 year
Time frame: From procedure completion till 5 years post-procedure
Carotid restenosis free survival up to 1 year
Time frame: From procedure completion till 1 year post-procedure
Carotid restenosis free survival up to 5 years
Time frame: From procedure completion till 5 years post-procedure
Rate of carotid reintervention
Time frame: From procedure completion till 5 years post-procedure
Feasibility of combined treatment
Time frame: At the procedure completion
NIHSS score change
Time frame: At 90 days post procedure
Freedom from stent thrombosis at 30 days
Time frame: At 30 days post procedure
Freedom from stent thrombosis at 90 days
Time frame: At 90 days post procedure
Freedom from stent thrombosis or in-stent restenosis up to 1 year
Time frame: At 1 year after procedure
Stent thrombosis or in-stent restenosis up to 5 years
Time frame: At 5 years after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 39022700Tekieli L, Afanasjev A, Mazgaj M, Borodetsky V, Sievert K, Ruzsa Z, Knapik M, Sirvinskas A, Mazurek A, Dzierwa K, Sanczuk T, Mosenko V, Urbanczyk-Zawadzka M, Trystula M, Paluszek P, Wiewiorka L, Stefaniak J, Pieniazek P, Slautaite I, Kwiatkowski T, Mackevicius A, Teitcher M, Sievert H, Grunwald IQ, Musialek P. A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE. Postepy Kardiol Interwencyjnej. 2024 Jun;20(2):172-193. doi: 10.5114/aic.2024.140963. Epub 2024 Jun 30.
- Derived from this study: PubMed 39007556Tekieli L, Dzierwa K, Grunwald IQ, Mazurek A, Urbanczyk-Zawadzka M, Wiewiorka L, Banys RP, Dabrowski W, Podlasek A, Weglarz E, Stefaniak J, Nizankowski RT, Musialek P. Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry. J Cardiovasc Surg (Torino). 2024 Jun;65(3):231-248. doi: 10.23736/S0021-9509.24.13093-5.
- 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.
Piotr Musialek, MD, DPhil principal investigator
Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow
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 Carotid Artery Stenosis and Acute Ischemic Stroke, run by John Paul II Hospital, Krakow at 1 site in Poland.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musialek, MD, DPhil (+48126142287, pmusialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from poor clinical status at 90 days (time frame: 90 days from index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195658, which also lists 2 linked publications.
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 28 Feb 2022.