An interventional study of Carotid Artery Stenting in Carotid Artery Diseases, sponsored by John Paul II Hospital, Krakow. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by John Paul II Hospital, Krakow · Not applicable, Interventional, and Treatment
All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.
Independent investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard™ routine use in all-comer population of consecutive patients with symptomatic or increased-stroke-risk asymptomatic carotid stenosis.
Increased-stroke-risk is defined as the following patient and/or lesion characteristics:
thrombus containing, documented progressive, irregular, ulcerated lesion; evidence of ipsilateral ischemic cerebral injury in MRI or CT imaging; contralateral stroke in relation to carotid stenosis; contralateral artery occlusion.
The main objective of this observational study is to evaluate (1) the periprocedural feasibility and efficacy of CGuard™ stent system in the treatment of carotid artery stenosis (2) long-term efficacy and safety of routine CGuard™ stent system use.
The study hypothesis is that the novel CGuard™ MicroNet® covered stent is safe and effective for a majority of consecutive patients considered to require carotid revascularization.
The multicenter arm of the project has a specific cohort descriptor: PARADIGM-EXTEND MC
257 studies on the registry are indexed under Carotid Artery Diseases; 58 are open to participants now.
This study's planned enrollment of 550 is above the median of 120 across 123 interventional studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →John Paul II Hospital, Krakow is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
Consecutive male and female patients older than 18 year with symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.
Device: Carotid Artery Stenting
Carotid artery stenting according to local clinical experience and ESC/ESVS guidelines using exclusively CGuard™, MicroNet covered stent under proximal or distal intraprocedural cerebral protection according to "tailored CAS" algorithm.
MACNE (Major Adverse Cardiac and Neurological Events)
Death, Stroke, Myocardial Infarction.
Time frame: 12 months
Procedural success
Successful stent delivery and deployment without complication
Time frame: Within 48 hours from index procedure
In-hospital MACNE (Major Adverse Cardiac and Neurological Events)
Death, Stroke, Myocardial Infarction within index hospitalization
Time frame: Within 48 hours from index procedure
30-day MACNE (Major Adverse Cardiac and Neurological Events)
Death, Stroke, Myocardial Infarction within 30 days
Time frame: 30 days
Incidence of any periprocedural complications
Any periprocedural complications
Time frame: Within 48 hours
Functional MRI efficacy assessment.
In case of fMRI evaluation, pre and postprocedural imaging.
Time frame: Within 48 hours
Diffusion Weighted MRI efficacy assessment.
In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging.
Time frame: Within 48 hours
Intravascular Ultrasound Stent Evaluation
In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation.
Time frame: Periprocedural
Ipsilateral Stroke incidence
Ischemic stoke at the site of index procedure.
Time frame: From one month until one year after the procedure.
Ipsilateral Stroke incidence
Ischemic stoke at the site of index procedure.
Time frame: From one year until five years after the procedure.
Any stroke incidence
Any stroke during study observational period.
Time frame: Within five years from the procedure.
Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel
Peak-systolic and End-diastolic Velocities assessed with DUS peri-proceduraly.
Time frame: Periprocedural
Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel
Peak-systolic and End-diastolic Velocities assessed with DUS 30 day after discharge.
Time frame: Within 30 days after index procedure.
Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel
Peak-systolic and End-diastolic Velocities assessed with DUS one year after discharge.
Time frame: One year after index procedure.
Plan to share: No
Started Sep 2015 (actual). Primary completion is estimated for Jun 2022, 81 months after the start.
Of 40 interventional studies with no phase under Carotid Artery Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's planned 81 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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John Paul II Hospital, Krakow