Carotid Artery DiseasesTOP-GUARDNCT04547387
TCAR Cerebral Protection And MicroNET-Covered Stent To Reduce Strokes
An observational study of Carotid Artery Diseases, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial summary
Prospective, single center clinical study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Trans-carotid access revascularization with MicroNET covered stent implantation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 10 May 2020to Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All-comer study in consecutive increased-risk patients (defined as those with symptoms or signs of carotid stenosis-related cerebral ischemic injury) eligible for trans-carotid access proximal cerebral protection and MicroNET-covered stent implantation based on the NeuroVascular Team evaluation and agreemment.
General Inclusion Criteria:
- Consecutive adult patients with clinical symptoms and/or signs (on cerebral imaging) of of carotid stenosis-related cerebral ischemic injury eligible for TCAR carotid revascularization according to NeuroVascular Team evaluation and local standards
- Symptomatic and asymptomatic carotid artery stenosis with ipsilateral ischemic lesions in brain imaging (CT or MRI)
- Informed written consent
- Declared compliance and consent to adhere to scheduled follow up and routine long term follow up
Angiographic Inclusion Criteria:
- De novo or neo-atherosclerotic carotid artery lesion
- NASCET criteria ≥50% carotid artery stenosis in patients with ipsilateral TIA, stroke or amaurosis fugax within last 6 months
- NASCET criteria ≥70-80% carotid artery stenosis in asymptomatic patients especially with ipsilateral ischemic lesions in brain imaging (CT or MRI)
General Exclusion Criteria:
- Lack of technical feasibility or logistic opportunity to perform procedure (device availability)
- Life expectancy less than 1 year
- Renal insufficiency with creatinine >3mg/dL
- Myocardial infarction within last 72 hours before procedure
- Pregnant women
- Coagulopathies
- Allergy to contrast media not amenable to pharmacotherapy
Angiographic Exclusion Criteria:
- Total carotid artery occlusion
- Stent in the carotid artery preventing artery cannulation or introduction of stent or protective device
- Anatomic variants preventing introduction of stent or protective device
- Significant common carotid artery stenosis proximal to target vessel
- Moving plaque in aortic arch
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Maloplska, 31-202
Piotr Musialek, Prof, +48126142287, p.musialek@szpitaljp2.krakow.pl
About this study
Official title: Carotid Artery Revascularization Using TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System to Reduce Strokes in Patients With Symptoms or Signs of Cerebral Ischemia: TOP-GUARD Study
Prospective, single center clinical study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention. MicroNET-covered stent is implanted using direct carotid artery access and temporary flow reversal to combine optimal intraprocedural cerebral protection and optimal plaque exclusion.
Read the detailed description
Prospective, single-center clinical study in consecutive patients undergoing carotid revascularization with MicroNET-covered stent implanted through direct carotid artery access with temporary, intraprocedural flow reversal neuroprotection to provide primary and secondary stroke prevention.
It is an open-label, non-randomized single-arm study supported by the grant from Jagiellonian University Medical college (K/ZDS/007819).
Stroke is a major health problem affecting individual patients and their families and entire societies with death and disability impact (fundamental disability cause in Poland, Europe, and the USA). Atherosclerotic carotid artery stenosis plays an important part in a stroke etiology through embolic and/or hemodynamic mechanism).
Endovascular treatment with first-generation carotid stents is inherently related to plaque and thrombus prolapse through stent struts, as confirmed with the intravascular imaging (IVUS and OCT), and monitoring of cerebral embolism by DW-MRI. Plaque prolapse related embolism may occur after neuroprotection device removal. Postprocedural plaque-prolapse related ischemic events are responsible for 40-60% complications up to 30 days, as indicated by 30-day results of large clinical trials (CAPTURE, CREST, or ICSS).
A successful attempt to address this problem has been an introduction and routine use of MicroNET-covered stent. The MicroNET attached to the metallic stent prevents intraluminal plaque prolapse. MRI imaging indicated a significant reduction of intraprocedural embolism and near-elimination of post-procedural brain embolism by CGuard application. Clinical research and meta-analysis of studies confirmed the safety and efficacy of the stent. Consistent results were demonstrated in registries such as PARADIGM.
Another critical approach in increasing the safety of the endovascular route of carotid revascularization is development and increased clinical uptake of minimally invasive endovascular strategies is the direct common carotid artery access for stenting procedures. This way, one can avoid femoral cannulation and navigation through the aorta and aortic arch branches. Trans-Carotid Arterial Revascularization (TCAR) offers a neuroprotection mechanism by a temporary reversal of the cerebral flow similar to Mo.Ma Ultra or GORE Flow Reversal systems, but without limitations of femoral access and aortic arch cannulation. TCAR system was CE marked in 2014, and more than 20 000 TCAR procedures were performed worldwide. A recent analysis by Yee et al. demonstrated that TCAR carotid stenting procedures are equivalent to surgical endarterectomy regarding safety and efficacy, but with lower invasiveness, avoiding the aortic arch (and its cannulation-related cerebral embolism) and shortened procedure time.
According to published studies and our own experience, proximal neuroprotection, and in particular, the one achieved through direct carotid artery access, minimizes cerebral (micro)embolization risk.
Our prospective TOP-GUARD study aims to evaluate early-, mid- and longterm outcome data (up to 5 years) on the results of carotid revascularization combining two systems that are currently considered safest: temporary cerebral flow-reversal during stent introduction via direct carotid artery access and MicroNET-covered stent implantation.
Both systems are CE-marked (from 2014), have been successfully used in our center, and will follow their on-label indications.
The TCAR system from SilkRoad Medical (EnRoute) is the preferred method to obtain flow reversal for transcervical CAS in the study. However, due to interruption of the EnRoute system supplies (COVID19, SARS-CoV-2 Pandemic), routinely available sheaths, catheters, and blood filters may be used according to literature to assemble the flow reversal circuit, enabling continuation of the study as per the Ethical Committee updated approval.
Consecutive patients with symptoms or signs of cerebral ischemia (ie. patients with an increased risk of complications when conventional carotid stents and neuroprotection systems are used) will undergo NeuroVascular Team (neurologist, interventionalist, and vascular surgeon) evaluation for their eligibility. They will be treated according to the center standard of care, including necessary peri- and postprocedural medication.
MRI cerebral imaging will be performed at baseline, 24-48 hours post-procedurally and at 90 days in 50% of study participants.
- Conditions
- Carotid Artery Diseases
- Being tested
- Trans-carotid access revascularization with MicroNET covered stent implantation
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-carotid access revascularization with MicroNET covered stent implantationDevice
Implantation of the micronet covered self-expanding carotid stent during temporary cerebral flow reversal achieved with direct common carotid artery puncture
| Study group | Role | What they receive |
|---|---|---|
| Carotid Artery Stenting | Consecutive patients with symptoms or signs of ischemic cerebral injury eligible for endovascular carotid artery revascularization using direct carotid artery access and MicroNET covered carotid stent plaque exclusion under cerebral protection by temporary flow reversal Receives: Device: Trans-carotid access revascularization with MicroNET covered stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate procedural success rate
Combined endpoint of TECHNICAL SUCCESS (insertion and removal of the embolic protection device, successful stent delivery, implantation and delivery system retrieval, with residual stenosis ≤30%) AND CLINICAL SUCCESS (freedom from MACNE (death, stroke, myocardial infarction) up to 48 hrs or hospital discharge)
Measured: 48 hours or hospital discharge, whatever comes first
Secondary outcomes (14)
Freedom from MACNE up to 30 days
Freedom from MACNE (death, ipsi- and contralateral stroke, myocardial infarction)
Measured: 30 days postprocedural
Freedom from MACNE up to 90 days
Freedom from MACNE (death, ipsi- and contralateral stroke, myocardial infarction)
Measured: 90 days postprocedural
Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions
Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions (evaluated in 50% of eligible study population)
Measured: 48 hours post procedure
Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions
Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions (non-contrast evaluation in 50% of eligible study population)
Measured: 90 days post procedure
Rate of complete stent expansion and apposition
Complete stent expansion and apposition on IVUS (if performed) in absence of plaque prolapse
Measured: During procedure
Rate of ipsilateral stroke
Rate of ipsilateral stroke
Measured: 30 days to 1 year post procedure
Rate of ipsilateral stroke
Rate of ipsilateral stroke
Measured: 1 year to 5 years post procedure
Rate of any stroke
Rate of any stroke
Measured: Up to 5 years post procedure
Stroke free survival
Stroke free survival
Measured: Up to 5 years post procedure
Ipsilateral stroke free survival
Ipsilateral stroke free survival
Measured: Up to 5 years post procedure
Rate of target vessel restenosis requiring treatment
Rate of target vessel restenosis requiring treatment
Measured: Up to 5 years post procedure
Ultrasound measured Peak Systolic Velocity in target artery
Ultrasound measured Peak Systolic Velocity in target artery
Measured: 48 hours post procedure
Ultrasound measured Peak Systolic Velocity in target artery
Ultrasound measured Peak Systolic Velocity in target artery
Measured: At 30 days post-procedure
Ultrasound measured Peak Systolic Velocity in target artery
Ultrasound measured Peak Systolic Velocity in target artery
Measured: At 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start10 May 2020
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies 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
- 50 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 HospitalMariusz Trystula, MD, PhD, Principal investigator, Department of Vascular Surgery, John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547387
- Sponsor's protocol ID
- TOP-GUARD
- Acronym
- TOP-GUARD
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yee EJ, Wang SK, Timsina LR, Ruiz-Herrera S, Liao JL, Donde NN, Fajardo AC, Motaganahalli RL. Propensity-Matched Outcomes of Transcarotid Artery Revascularization Versus Carotid Endarterectomy. J Surg Res. 2020 Aug;252:22-29. doi: 10.1016/j.jss.2019.12.003. Epub 2020 Mar 26.
PubMed 32222590Musialek P, Mazurek A, Trystula M, Borratynska A, Lesniak-Sobelga A, Urbanczyk M, Banys RP, Brzychczy A, Zajdel W, Partyka L, Zmudka K, Podolec P. Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard MicroNet-covered embolic prevention stent system. EuroIntervention. 2016 Aug 5;12(5):e658-70. doi: 10.4244/EIJY16M05_02.
PubMed 27180302Mazurek A, Borratynska A, Malinowski KP, Brozda M, Gancarczyk U, Dluzniewska N, Czyz L, Duplicka M, Sobieraj E, Trystula M, Drazkiewicz T, Podolec P, Musialek P. MicroNET-covered stents for embolic prevention in patients undergoing carotid revascularisation: twelve-month outcomes from the PARADIGM study. EuroIntervention. 2020 Dec 4;16(11):e950-e952. doi: 10.4244/EIJ-D-19-01014. No abstract available.
PubMed 32482614Chang DW, Schubart PJ, Veith FJ, Zarins CK. A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: Why it may be a better carotid artery intervention. J Vasc Surg. 2004 May;39(5):994-1002. doi: 10.1016/j.jvs.2004.01.045.
PubMed 15111851Criado E, Fontcuberta J, Orgaz A, Flores A, Doblas M. Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents. J Vasc Surg. 2007 Nov;46(5):864-9. doi: 10.1016/j.jvs.2007.07.028.
PubMed 17980271Pipinos II, Johanning JM, Pham CN, Soundararajan K, Lynch TG. Transcervical approach with protective flow reversal for carotid angioplasty and stenting. J Endovasc Ther. 2005 Aug;12(4):446-53. doi: 10.1583/05-1561.1.
PubMed 16048376Trystula M, VAN Herzeele I, Kolvenbach R, Tekieli L, Fonteyne C, Mazurek A, Dzierwa K, Chmiel J, Lindsay J, Kwiatkowski T, Hydzik A, Oplawski M, Bederski K, Musialek P. Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study. J Cardiovasc Surg (Torino). 2024 Jun;65(3):181-194. doi: 10.23736/S0021-9509.24.13121-7.
PubMed 39007552
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Revascularization Using TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System to Reduce Strokes in Patients With Symptoms or Signs of Cerebral Ischemia: TOP-GUARD Study
- ClinicalTrials.gov ID
- NCT04547387
- Acronym / sponsor ID
- TOP-GUARD / TOP-GUARD
- Conditions
- Carotid Artery Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 14 Sep 2020 (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 study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention. MicroNET-covered stent is implanted using direct carotid artery access and temporary flow reversal to combine optimal intraprocedural cerebral protection and optimal plaque exclusion.
Detailed description
Prospective, single-center clinical study in consecutive patients undergoing carotid revascularization with MicroNET-covered stent implanted through direct carotid artery access with temporary, intraprocedural flow reversal neuroprotection to provide primary and secondary stroke prevention.
It is an open-label, non-randomized single-arm study supported by the grant from Jagiellonian University Medical college (K/ZDS/007819).
Stroke is a major health problem affecting individual patients and their families and entire societies with death and disability impact (fundamental disability cause in Poland, Europe, and the USA). Atherosclerotic carotid artery stenosis plays an important part in a stroke etiology through embolic and/or hemodynamic mechanism).
Endovascular treatment with first-generation carotid stents is inherently related to plaque and thrombus prolapse through stent struts, as confirmed with the intravascular imaging (IVUS and OCT), and monitoring of cerebral embolism by DW-MRI. Plaque prolapse related embolism may occur after neuroprotection device removal. Postprocedural plaque-prolapse related ischemic events are responsible for 40-60% complications up to 30 days, as indicated by 30-day results of large clinical trials (CAPTURE, CREST, or ICSS).
A successful attempt to address this problem has been an introduction and routine use of MicroNET-covered stent. The MicroNET attached to the metallic stent prevents intraluminal plaque prolapse. MRI imaging indicated a significant reduction of intraprocedural embolism and near-elimination of post-procedural brain embolism by CGuard application. Clinical research and meta-analysis of studies confirmed the safety and efficacy of the stent. Consistent results were demonstrated in registries such as PARADIGM.
Another critical approach in increasing the safety of the endovascular route of carotid revascularization is development and increased clinical uptake of minimally invasive endovascular strategies is the direct common carotid artery access for stenting procedures. This way, one can avoid femoral cannulation and navigation through the aorta and aortic arch branches. Trans-Carotid Arterial Revascularization (TCAR) offers a neuroprotection mechanism by a temporary reversal of the cerebral flow similar to Mo.Ma Ultra or GORE Flow Reversal systems, but without limitations of femoral access and aortic arch cannulation. TCAR system was CE marked in 2014, and more than 20 000 TCAR procedures were performed worldwide. A recent analysis by Yee et al. demonstrated that TCAR carotid stenting procedures are equivalent to surgical endarterectomy regarding safety and efficacy, but with lower invasiveness, avoiding the aortic arch (and its cannulation-related cerebral embolism) and shortened procedure time.
According to published studies and our own experience, proximal neuroprotection, and in particular, the one achieved through direct carotid artery access, minimizes cerebral (micro)embolization risk.
Our prospective TOP-GUARD study aims to evaluate early-, mid- and longterm outcome data (up to 5 years) on the results of carotid revascularization combining two systems that are currently considered safest: temporary cerebral flow-reversal during stent introduction via direct carotid artery access and MicroNET-covered stent implantation.
Both systems are CE-marked (from 2014), have been successfully used in our center, and will follow their on-label indications.
The TCAR system from SilkRoad Medical (EnRoute) is the preferred method to obtain flow reversal for transcervical CAS in the study. However, due to interruption of the EnRoute system supplies (COVID19, SARS-CoV-2 Pandemic), routinely available sheaths, catheters, and blood filters may be used according to literature to assemble the flow reversal circuit, enabling continuation of the study as per the Ethical Committee updated approval.
Consecutive patients with symptoms or signs of cerebral ischemia (ie. patients with an increased risk of complications when conventional carotid stents and neuroprotection systems are used) will undergo NeuroVascular Team (neurologist, interventionalist, and vascular surgeon) evaluation for their eligibility. They will be treated according to the center standard of care, including necessary peri- and postprocedural medication.
MRI cerebral imaging will be performed at baseline, 24-48 hours post-procedurally and at 90 days in 50% of study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Artery Stenting | – | Device: Trans-carotid access revascularization with MicroNET covered stent implantationConsecutive patients with symptoms or signs of ischemic cerebral injury eligible for endovascular carotid artery revascularization using direct carotid artery access and MicroNET covered carotid stent plaque exclusion under cerebral protection by temporary flow reversal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comer study in consecutive increased-risk patients (defined as those with symptoms or signs of carotid stenosis-related cerebral ischemic injury) eligible for trans-carotid access proximal cerebral protection and MicroNET-covered stent implantation based on the NeuroVascular Team evaluation and agreemment.
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 |
|---|---|---|
| Trans-carotid access revascularization with MicroNET covered stent implantationImplantation of the micronet covered self-expanding carotid stent during temporary cerebral flow reversal achieved with direct common carotid artery puncture | Device | Carotid Artery Stenting |
Primary outcome
Immediate procedural success rate
Time frame: 48 hours or hospital discharge, whatever comes first
Combined endpoint of TECHNICAL SUCCESS (insertion and removal of the embolic protection device, successful stent delivery, implantation and delivery system retrieval, with residual stenosis ≤30%) AND CLINICAL SUCCESS (freedom from MACNE (death, stroke, myocardial infarction) up to 48 hrs or hospital discharge)
14 secondary outcomes
Freedom from MACNE up to 30 days
Time frame: 30 days postprocedural
Freedom from MACNE up to 90 days
Time frame: 90 days postprocedural
Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions
Time frame: 48 hours post procedure
Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions
Time frame: 90 days post procedure
Rate of complete stent expansion and apposition
Time frame: During procedure
Rate of ipsilateral stroke
Time frame: 30 days to 1 year post procedure
Rate of ipsilateral stroke
Time frame: 1 year to 5 years post procedure
Rate of any stroke
Time frame: Up to 5 years post procedure
Stroke free survival
Time frame: Up to 5 years post procedure
Ipsilateral stroke free survival
Time frame: Up to 5 years post procedure
Rate of target vessel restenosis requiring treatment
Time frame: Up to 5 years post procedure
Ultrasound measured Peak Systolic Velocity in target artery
Time frame: 48 hours post procedure
Ultrasound measured Peak Systolic Velocity in target artery
Time frame: At 30 days post-procedure
Ultrasound measured Peak Systolic Velocity in target artery
Time frame: At 1 year post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 32222590Yee EJ, Wang SK, Timsina LR, Ruiz-Herrera S, Liao JL, Donde NN, Fajardo AC, Motaganahalli RL. Propensity-Matched Outcomes of Transcarotid Artery Revascularization Versus Carotid Endarterectomy. J Surg Res. 2020 Aug;252:22-29. doi: 10.1016/j.jss.2019.12.003. Epub 2020 Mar 26.
- Background: PubMed 27180302Musialek P, Mazurek A, Trystula M, Borratynska A, Lesniak-Sobelga A, Urbanczyk M, Banys RP, Brzychczy A, Zajdel W, Partyka L, Zmudka K, Podolec P. Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard MicroNet-covered embolic prevention stent system. EuroIntervention. 2016 Aug 5;12(5):e658-70. doi: 10.4244/EIJY16M05_02.
- Background: PubMed 32482614Mazurek A, Borratynska A, Malinowski KP, Brozda M, Gancarczyk U, Dluzniewska N, Czyz L, Duplicka M, Sobieraj E, Trystula M, Drazkiewicz T, Podolec P, Musialek P. MicroNET-covered stents for embolic prevention in patients undergoing carotid revascularisation: twelve-month outcomes from the PARADIGM study. EuroIntervention. 2020 Dec 4;16(11):e950-e952. doi: 10.4244/EIJ-D-19-01014. No abstract available.
- Background: PubMed 15111851Chang DW, Schubart PJ, Veith FJ, Zarins CK. A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: Why it may be a better carotid artery intervention. J Vasc Surg. 2004 May;39(5):994-1002. doi: 10.1016/j.jvs.2004.01.045.
- Background: PubMed 17980271Criado E, Fontcuberta J, Orgaz A, Flores A, Doblas M. Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents. J Vasc Surg. 2007 Nov;46(5):864-9. doi: 10.1016/j.jvs.2007.07.028.
- Background: PubMed 16048376Pipinos II, Johanning JM, Pham CN, Soundararajan K, Lynch TG. Transcervical approach with protective flow reversal for carotid angioplasty and stenting. J Endovasc Ther. 2005 Aug;12(4):446-53. doi: 10.1583/05-1561.1.
- Derived from this study: PubMed 39007552Trystula M, VAN Herzeele I, Kolvenbach R, Tekieli L, Fonteyne C, Mazurek A, Dzierwa K, Chmiel J, Lindsay J, Kwiatkowski T, Hydzik A, Oplawski M, Bederski K, Musialek P. Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study. J Cardiovasc Surg (Torino). 2024 Jun;65(3):181-194. doi: 10.23736/S0021-9509.24.13121-7.
- Individual participant dataSharing planned: No
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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.
Piotr Musialek, MD, DPhil principal investigator
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Mariusz Trystula, MD, PhD principal investigator
Department of Vascular Surgery, John Paul II Hospital
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 Diseases, 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?
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 6 Jan 2021. 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?
Results are not available in the source record.
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?
Immediate procedural success rate (time frame: 48 hours or hospital discharge, whatever comes first). 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 NCT04547387, which also lists 7 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 6 Jan 2021.