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

Primary Purpose

Carotid Artery Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Carotid Artery Stenting

About this trial

This is an interventional treatment trial for Carotid Artery Diseases focused on measuring Stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carotid Artery Stenting

Arm Description

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.

Outcomes

Primary Outcome Measures

MACNE (Major Adverse Cardiac and Neurological Events)

Death, Stroke, Myocardial Infarction.

Secondary Outcome Measures

Procedural success

Successful stent delivery and deployment without complication

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

Death, Stroke, Myocardial Infarction within index hospitalization

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

Death, Stroke, Myocardial Infarction within 30 days

Incidence of any periprocedural complications

Any periprocedural complications

Functional MRI efficacy assessment.

In case of fMRI evaluation, pre and postprocedural imaging.

Diffusion Weighted MRI efficacy assessment.

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

Intravascular Ultrasound Stent Evaluation

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

Ipsilateral Stroke incidence

Ischemic stoke at the site of index procedure.

Ipsilateral Stroke incidence

Ischemic stoke at the site of index procedure.

Any stroke incidence

Any stroke during study observational period.

Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel

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

Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel

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

Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel

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

Full Information

NCT ID

NCT04271033

First Posted

January 15, 2020

Last Updated

March 14, 2022

Sponsor

John Paul II Hospital, Krakow

Collaborators

Jagiellonian University

1. Study Identification

Unique Protocol Identification Number

NCT04271033

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2015 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

John Paul II Hospital, Krakow

Collaborators

Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Artery Diseases

Keywords

Stenting

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm registry

Masking

None (Open Label)

Allocation

N/A

Enrollment

550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carotid Artery Stenting

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Carotid Artery Stenting

Intervention Description

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.

Primary Outcome Measure Information:

Title

MACNE (Major Adverse Cardiac and Neurological Events)

Description

Death, Stroke, Myocardial Infarction.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Procedural success

Description

Successful stent delivery and deployment without complication

Time Frame

Within 48 hours from index procedure

Title

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

Description

Death, Stroke, Myocardial Infarction within index hospitalization

Time Frame

Within 48 hours from index procedure

Title

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

Description

Death, Stroke, Myocardial Infarction within 30 days

Time Frame

30 days

Title

Incidence of any periprocedural complications

Description

Any periprocedural complications

Time Frame

Within 48 hours

Title

Functional MRI efficacy assessment.

Description

In case of fMRI evaluation, pre and postprocedural imaging.

Time Frame

Within 48 hours

Title

Diffusion Weighted MRI efficacy assessment.

Description

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

Time Frame

Within 48 hours

Title

Intravascular Ultrasound Stent Evaluation

Description

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

Time Frame

Periprocedural

Title

Ipsilateral Stroke incidence

Description

Ischemic stoke at the site of index procedure.

Time Frame

From one month until one year after the procedure.

Title

Ipsilateral Stroke incidence

Description

Ischemic stoke at the site of index procedure.

Time Frame

From one year until five years after the procedure.

Title

Any stroke incidence

Description

Any stroke during study observational period.

Time Frame

Within five years from the procedure.

Title

Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel

Description

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

Time Frame

Periprocedural

Title

Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel

Description

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

Time Frame

Within 30 days after index procedure.

Title

Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel

Description

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

Time Frame

One year after index procedure.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Piotr Musialek, MD, PhD

Phone

+48126142287

p.musialek@szpitaljp2.krakow.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piotr Musialek, MD, PhD

Organizational Affiliation

Jagiellonian University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Kraków

State/Province

Maloplska

ZIP/Postal Code

31-202

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piotr Musialek, Prof

Phone

+48126142287

p.musialek@szpitaljp2.krakow.pl

12. IPD Sharing Statement

Plan to Share IPD

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

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