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

NCT04271033 | Recruiting DMC

• 1 other identifier: PARADIGM-EXTEND
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Diseases

Keywords

Stenting

Outcome Measures

Primary Outcomes (1)

• MACNE (Major Adverse Cardiac and Neurological Events)

  Death, Stroke, Myocardial Infarction.

  12 months

Secondary Outcomes (13)

• Procedural success

  Within 48 hours from index procedure

• In-hospital MACNE (Major Adverse Cardiac and Neurological Events)

  Within 48 hours from index procedure

• 30-day MACNE (Major Adverse Cardiac and Neurological Events)

  30 days

• Incidence of any periprocedural complications

  Within 48 hours

• Functional MRI efficacy assessment.

  Within 48 hours

Study Arms (1)

Carotid Artery Stenting

EXPERIMENTAL

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

Interventions

Carotid Artery Stenting DEVICE

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.

Carotid Artery Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead
• Jagiellonian University: collaborator

Study Sites (1)

Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Krakow, Maloplska, 31-202, Poland

RECRUITING

Related 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. No abstract available. English, Spanish.

  PMID: 29425606 BACKGROUND

• 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.

  PMID: 26890472 BACKGROUND

• 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.

  PMID: 26886419 BACKGROUND

• 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.

  PMID: 28473130 BACKGROUND

• 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.

  PMID: 30063301 BACKGROUND

• 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.

  PMID: 23582886 BACKGROUND

• 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.

  PMID: 28427600 BACKGROUND

• 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.

  PMID: 26292586 BACKGROUND

• 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.

  PMID: 18540694 BACKGROUND

• 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. No abstract available.

  PMID: 29192895 BACKGROUND

• 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. No abstract available.

  PMID: 27733691 BACKGROUND

• 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.

  PMID: 28798779 BACKGROUND

• 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.

  PMID: 30522670 BACKGROUND

• 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. No abstract available.

  PMID: 24526550 BACKGROUND

• 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 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.

  PMID: 27180302 RESULT

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Piotr Musialek, MD, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, PhD

CONTACT

+48126142287; p.musialek@szpitaljp2.krakow.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm registry

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 17, 2020
• Study Start: September 1, 2015
• Primary Completion: June 1, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)