MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization

Carotid Artery Diseases Clinical Trial

— PARADIGM-EXT  

Official title:

Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04271033
• Other study ID #: PARADIGM-EXTEND
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: June 2026

Study information

• Verified date: March 2022
• Source: John Paul II Hospital, Krakow
• Contact: Piotr Musialek, MD, PhD
• Phone: +48126142287
• Email: p.musialek[@]szpitaljp2.krakow.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: June 2026
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

• Patient > 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care

• Signed informed consent

• Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.

Angiographic Inclusion Criteria:

• De-novo atherosclerotic lesions or neo-atherosclerosis

• Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis =50% assessed in angiography with NASCET method or

• Asymptomatic patients with index artery stenosis =70-80% assessed in angiography with NASCET method

General Exclusion Criteria:

• Lack of NeuroVascular Team agreement on carotid revascularization indication

• Lack of signed informed consent

• Estimated life expectancy less than 1 year

• Chronic renal failure with serum creatinine level > 3.0 mg/dL

• Myocardial Infarction within 72 hours prior to index procedure.

• Pregnant women

• Diagnosed coagulopathies

• History of contrast media allergy, not reacting to pharmacotherapy

Angiographic Exclusion Criteria:

• Index lesion occlusion

• Common carotid artery stent protruding to aortic arch

• Anatomical conditions restricting stent implantation

• Significant common carotid artery stenosis proximal to index lesion (unless treated)

Related Conditions & MeSH terms

• Carotid Artery Diseases

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Cardiac and Vascular Diseases, The John Paul II Hospital	Kraków	Maloplska

Sponsors (2)

Lead Sponsor	Collaborator
John Paul II Hospital, Krakow	Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (15)

Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debusa S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylora AR, Roffi M, Rotherb J, Sprynger M, Tendera M, Tepe G, Venermoa M, Vlachopoulos C, Desormais I. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Rev Esp Cardiol (Engl Ed). 2018 Feb;71(2):111. doi: 10.1016/j.rec.2017.12.014. English, Spanish. — View Citation

Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, Moore WS, Hill MD, Mantese VA, Clark WM, Timaran CH, Heck D, Leimgruber PP, Sheffet AJ, Howard VJ, Chaturvedi S, Lal BK, Voeks JH, Hobson RW 2nd; CREST Investigators. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med. 2016 Mar 17;374(11):1021-31. doi: 10.1056/NEJMoa1505215. Epub 2016 Feb 18. — View Citation

de Donato G, Setacci F, Sirignano P, Galzerano G, Cappelli A, Setacci C. Optical coherence tomography after carotid stenting: rate of stent malapposition, plaque prolapse and fibrous cap rupture according to stent design. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):579-87. doi: 10.1016/j.ejvs.2013.03.005. Epub 2013 Apr 10. — View Citation

Janczak D, Malinowski M, Ziomek A, Kobecki J, Lesniak M, Dorobisz T, Dorobisz K, Janczak D, Chabowski M. Carotid artery stenting versus endarterectomy for the treatment of both symptomatic and asymptomatic patients with carotid artery stenosis: 2 years' experience in a high-volume center. Adv Clin Exp Med. 2018 Dec;27(12):1691-1695. doi: 10.17219/acem/75902. — View Citation

Kotsugi M, Takayama K, Myouchin K, Wada T, Nakagawa I, Nakagawa H, Taoka T, Kurokawa S, Nakase H, Kichikawa K. Carotid Artery Stenting: Investigation of Plaque Protrusion Incidence and Prognosis. JACC Cardiovasc Interv. 2017 Apr 24;10(8):824-831. doi: 10.1016/j.jcin.2017.01.029. — View Citation

Musialek P, Grunwald IQ. How asymptomatic is "asymptomatic" carotid stenosis? Resolving fundamental confusion(s) - and confusions yet to be resolved. Pol Arch Intern Med. 2017 Nov 30;127(11):718-719. doi: 10.20452/pamw.4157. Epub 2017 Nov 30. — View Citation

Musialek P, Hopf-Jensen S. Commentary: Carotid Artery Revascularization for Stroke Prevention: A New Era. J Endovasc Ther. 2017 Feb;24(1):138-148. doi: 10.1177/1526602816671263. Epub 2016 Oct 13. — View Citation

Musialek P, Hopkins LN, Siddiqui AH. One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field. Postepy Kardiol Interwencyjnej. 2017;13(2):95-106. doi: 10.5114/pwki.2017.69012. Epub 2017 Jul 19. Review. — View Citation

Musialek 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 revasc — View Citation

Musialek P. TASTE-less endpoint of 30-day mortality (and some other issues with TASTE) in evaluating the effectiveness of thrombus aspiration in STEMI: not the "evidence" to change the current practice of routine consideration of manual thrombus extraction. Kardiol Pol. 2014;72(6):479-87. doi: 10.5603/KP.a2014.0022. Epub 2014 Feb 14. — View Citation

Pieniazek P, Musialek P, Kablak-Ziembicka A, Tekieli L, Motyl R, Przewlocki T, Moczulski Z, Pasowicz M, Sokolowski A, Lesniak-Sobelga A, Zmudka K, Tracz W. Carotid artery stenting with patient- and lesion-tailored selection of the neuroprotection system and stent type: early and 5-year results from a prospective academic registry of 535 consecutive procedures (TARGET-CAS). J Endovasc Ther. 2008 Jun;15(3):249-62. doi: 10.1583/07-2264.1. — View Citation

Rosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, Wechsler L, Jaff MR, Gray W; ACT I Investigators. Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016 Mar 17;374(11):1011-20. doi: 10.1056/NEJMoa1515706. Epub 2016 Feb 17. — View Citation

Sardar P, Chatterjee S, Aronow HD, Kundu A, Ramchand P, Mukherjee D, Nairooz R, Gray WA, White CJ, Jaff MR, Rosenfield K, Giri J. Carotid Artery Stenting Versus Endarterectomy for Stroke Prevention: A Meta-Analysis of Clinical Trials. J Am Coll Cardiol. 2017 May 9;69(18):2266-2275. doi: 10.1016/j.jacc.2017.02.053. — View Citation

Schofer J, Musialek P, Bijuklic K, Kolvenbach R, Trystula M, Siudak Z, Sievert H. A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1229-1234. doi: 10.1016/j.jcin.2015.04.016. — View Citation

Stabile E, de Donato G, Musialek P, De Loose K, Nerla R, Sirignano P, Chianese S, Mazurek A, Tesorio T, Bosiers M, Setacci C, Speziale F, Micari A, Esposito G. Use of Dual-Layered Stents in Endovascular Treatment of Extracranial Stenosis of the Internal Carotid Artery: Results of a Patient-Based Meta-Analysis of 4 Clinical Studies. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2405-2411. doi: 10.1016/j.jcin.2018.06.047. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACNE (Major Adverse Cardiac and Neurological Events)	Death, Stroke, Myocardial Infarction.	12 months
Secondary	Procedural success	Successful stent delivery and deployment without complication	Within 48 hours from index procedure
Secondary	In-hospital MACNE (Major Adverse Cardiac and Neurological Events)	Death, Stroke, Myocardial Infarction within index hospitalization	Within 48 hours from index procedure
Secondary	30-day MACNE (Major Adverse Cardiac and Neurological Events)	Death, Stroke, Myocardial Infarction within 30 days	30 days
Secondary	Incidence of any periprocedural complications	Any periprocedural complications	Within 48 hours
Secondary	Functional MRI efficacy assessment.	In case of fMRI evaluation, pre and postprocedural imaging.	Within 48 hours
Secondary	Diffusion Weighted MRI efficacy assessment.	In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging.	Within 48 hours
Secondary	Intravascular Ultrasound Stent Evaluation	In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation.	Periprocedural
Secondary	Ipsilateral Stroke incidence	Ischemic stoke at the site of index procedure.	From one month until one year after the procedure.
Secondary	Ipsilateral Stroke incidence	Ischemic stoke at the site of index procedure.	From one year until five years after the procedure.
Secondary	Any stroke incidence	Any stroke during study observational period.	Within five years from the procedure.
Secondary	Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel	Peak-systolic and End-diastolic Velocities assessed with DUS peri-proceduraly.	Periprocedural
Secondary	Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel	Peak-systolic and End-diastolic Velocities assessed with DUS 30 day after discharge.	Within 30 days after index procedure.
Secondary	Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel	Peak-systolic and End-diastolic Velocities assessed with DUS one year after discharge.	One year after index procedure.