Clincosm LogoSign in Get a demo

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

Sponsor
John Paul II Hospital, Krakow (Other)
Overall Status
Recruiting
CT.gov ID
NCT04271033
Collaborator
Jagiellonian University (Other)
550
Enrollment
1
Location
1
Arm
129
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Carotid Artery Stenting
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
550 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single arm registrySingle arm registry
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carotid Artery Stenting

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.

Outcome Measures

Primary Outcome Measures

  1. MACNE (Major Adverse Cardiac and Neurological Events) [12 months]

    Death, Stroke, Myocardial Infarction.

Secondary Outcome Measures

  1. Procedural success [Within 48 hours from index procedure]

    Successful stent delivery and deployment without complication

  2. In-hospital MACNE (Major Adverse Cardiac and Neurological Events) [Within 48 hours from index procedure]

    Death, Stroke, Myocardial Infarction within index hospitalization

  3. 30-day MACNE (Major Adverse Cardiac and Neurological Events) [30 days]

    Death, Stroke, Myocardial Infarction within 30 days

  4. Incidence of any periprocedural complications [Within 48 hours]

    Any periprocedural complications

  5. Functional MRI efficacy assessment. [Within 48 hours]

    In case of fMRI evaluation, pre and postprocedural imaging.

  6. Diffusion Weighted MRI efficacy assessment. [Within 48 hours]

    In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging.

  7. Intravascular Ultrasound Stent Evaluation [Periprocedural]

    In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation.

  8. Ipsilateral Stroke incidence [From one month until one year after the procedure.]

    Ischemic stoke at the site of index procedure.

  9. Ipsilateral Stroke incidence [From one year until five years after the procedure.]

    Ischemic stoke at the site of index procedure.

  10. Any stroke incidence [Within five years from the procedure.]

    Any stroke during study observational period.

  11. Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel [Periprocedural]

    Peak-systolic and End-diastolic Velocities assessed with DUS peri-proceduraly.

  12. Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel [Within 30 days after index procedure.]

    Peak-systolic and End-diastolic Velocities assessed with DUS 30 day after discharge.

  13. Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel [One year after index procedure.]

    Peak-systolic and End-diastolic Velocities assessed with DUS one year after discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiac and Vascular Diseases, The John Paul II Hospital Kraków Maloplska Poland 31-202

Sponsors and Collaborators

  • John Paul II Hospital, Krakow
  • Jagiellonian University

Investigators

  • Principal Investigator: Piotr Musialek, MD, PhD, Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier:
NCT04271033
Other Study ID Numbers:
  • PARADIGM-EXTEND
First Posted:
Feb 17, 2020
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by John Paul II Hospital, Krakow
Stenting
Additional relevant MeSH terms:
Carotid Artery Diseases

Study Results

No Results Posted as of Mar 29, 2022