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

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

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).

Study Overview

• Status: Unknown
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Procedure: Carotid Artery Stenting without Protection; Procedure: Carotid Artery Stenting with Proximal Protection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • Recruiting
      • Department of Diagnostic and Interventional Neuroradiology
      • Sub-Investigator: Christian Roth, MD
      • Contact: Panagiotis Papanagiotou, MD; Phone Number: 24302 49684116; Email: provenon.study@me.com
      • Contact: Christian Roth, MD; Phone Number: 24302 49684116; Email: provenon.study@me.com
      • Principal Investigator: Wolfgang Reith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carotid Artery Stenting without Protection; Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device	Procedure: Carotid Artery Stenting without Protection; Carotid artery angioplasty and stenting without cerebral embolic protection
Active Comparator: Carotid Artery Stenting with Proximal Protection; 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	Procedure: Carotid Artery Stenting with Proximal Protection; Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging	Day 1-3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment		Day 30
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.	Day 0
Access site vascular complications, defined as need for surgical repair or blood transfusion		Day 0-7

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Principal Investigator: Wolfgang Reith, MD, Saarland University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2011
• Last Update Submitted That Met QC Criteria: December 2, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Stenting; CAS; Carotid Artery; proximal protection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: PROVENON01