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PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)

Primary Purpose

Carotid Artery Stenosis

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Carotid Artery Stenting with Proximal Protection

Carotid Artery Stenting without Protection

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring Carotid Artery, Stenting, CAS, proximal protection

Eligibility Criteria

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

Inclusion Criteria:

Male and female ≥ 18 years old;
Suitable/Eligible for carotid artery revascularization;
Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
Adequate clinical conditions to perform DW-MRI.
Ability of the individual to understand the character and the consequences of clinical trial.
Signed and dated informed consent provided before the beginning of any intervention.
Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial.

Exclusion Criteria:

Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
Persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry).
Intracranial mass lesion (i.e., abscess, tumor, or other infection).
peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results.
Lactation.
Arterio-venous malformation in the territory of the target carotid artery.
Any disease or medication that affects local hemostasis,
Participation in other clinical trials during the present clinical trial or within the last month.
Medical or psychological condition that would not permit completion of the trial or signing of informed consent.

Sites / Locations

Department of Diagnostic and Interventional NeuroradiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Carotid Artery Stenting without Protection

Carotid Artery Stenting with Proximal Protection

Arm Description

Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device

Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and with a proximal embolic protection device provided by the GORE Neuro Protection System

Outcomes

Primary Outcome Measures

The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging

Secondary Outcome Measures

Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment

Technical Success of the procedure

Subjects (both groups) who due to technical reaseons are unable to performe carotid artery stenting will be considered as technical failures. Subjects who are unable to tolerate flow reversal (in group 2) and have their procedures completed without embolic protection or other methods will be also considered as technical failures.

Access site vascular complications, defined as need for surgical repair or blood transfusion

Full Information

NCT ID

NCT01331473

First Posted

March 30, 2011

Last Updated

December 2, 2011

Sponsor

Universität des Saarlandes

1. Study Identification

Unique Protocol Identification Number

NCT01331473

Brief Title

PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

Acronym

PROVENON

Official Title

PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Universität des Saarlandes

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the incidence of new ischemic brain injury detected with magnetic resonance imaging (MRI) after carotid artery stenting in patients treated with and without proximal cerebral protection (Gore Flow Reversal System).

Detailed Description

Primary Objective: The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting between patients treated with proximal cerebral protection (Gore Flow Reversal System) and without cerebral protection. Secondary Objective: Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (DWI) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.

6. Conditions and Keywords

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

Carotid Artery Stenosis

Keywords

Carotid Artery, Stenting, CAS, proximal protection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carotid Artery Stenting without Protection

Arm Type

Active Comparator

Arm Description

Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device

Arm Title

Carotid Artery Stenting with Proximal Protection

Arm Type

Active Comparator

Arm Description

Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and with a proximal embolic protection device provided by the GORE Neuro Protection System

Intervention Type

Procedure

Intervention Name(s)

Carotid Artery Stenting with Proximal Protection

Intervention Description

Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System

Intervention Type

Procedure

Intervention Name(s)

Carotid Artery Stenting without Protection

Intervention Description

Carotid artery angioplasty and stenting without cerebral embolic protection

Primary Outcome Measure Information:

Title

The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging

Time Frame

Day 1-3

Secondary Outcome Measure Information:

Title

Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment

Time Frame

Day 30

Title

Technical Success of the procedure

Description

Time Frame

Day 0

Title

Access site vascular complications, defined as need for surgical repair or blood transfusion

Time Frame

Day 0-7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female ≥ 18 years old; Suitable/Eligible for carotid artery revascularization; Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment. Adequate clinical conditions to perform DW-MRI. Ability of the individual to understand the character and the consequences of clinical trial. Signed and dated informed consent provided before the beginning of any intervention. Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial. Exclusion Criteria: Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure. Persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry). Intracranial mass lesion (i.e., abscess, tumor, or other infection). peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results. Lactation. Arterio-venous malformation in the territory of the target carotid artery. Any disease or medication that affects local hemostasis, Participation in other clinical trials during the present clinical trial or within the last month. Medical or psychological condition that would not permit completion of the trial or signing of informed consent.

Central Contact Person:

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

Panagiotis Papanagiotou, MD

Phone

+49684116

Ext

24302

provenon.study@me.com

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

Christian Roth, MD

Phone

+49684116

Ext

24302

provenon.study@me.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Reith, MD

Organizational Affiliation

Saarland University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Diagnostic and Interventional Neuroradiology

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66424

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Panagiotis Papanagiotou, MD

Phone

49684116

Ext

24302

provenon.study@me.com

First Name & Middle Initial & Last Name & Degree

Christian Roth, MD

Phone

49684116

Ext

24302

provenon.study@me.com

First Name & Middle Initial & Last Name & Degree

Wolfgang Reith, MD

First Name & Middle Initial & Last Name & Degree

Panagiotis Papanagiotou, MD

First Name & Middle Initial & Last Name & Degree

Christian Roth, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19198823

Citation

Grunwald IQ, Papanagiotou P, Roth C, Fassbender K, Karp K, Krick C, Schieber H, Muller M, Haass A, Reith W. Lesion load in unprotected carotid artery stenting. Neuroradiology. 2009 May;51(5):313-7. doi: 10.1007/s00234-008-0491-6. Epub 2009 Feb 6.

Results Reference

background

PubMed Identifier

17205314

Citation

Grunwald IQ, Papanagiotou P, Struffert T, Politi M, Krick C, Romaike BF, Ahlhelm F, Reith W. Reversal of flow during carotid artery stenting: use of the Parodi antiembolism system. Neuroradiology. 2007 Mar;49(3):237-41. doi: 10.1007/s00234-006-0178-9. Epub 2007 Jan 5.

Results Reference

background

PubMed Identifier

16888277

Citation

Kastrup A, Nagele T, Groschel K, Schmidt F, Vogler E, Schulz J, Ernemann U. Incidence of new brain lesions after carotid stenting with and without cerebral protection. Stroke. 2006 Sep;37(9):2312-6. doi: 10.1161/01.STR.0000236492.86303.85. Epub 2006 Aug 3.

Results Reference

background

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PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

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