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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Saarland University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Saarland University
ClinicalTrials.gov Identifier:
NCT01331473
First received: March 30, 2011
Last updated: December 2, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention Phase
Carotid Artery Stenosis
Procedure: Carotid Artery Stenting with Proximal Protection
Procedure: Carotid Artery Stenting without Protection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.

Further study details as provided by Saarland University:

Primary Outcome Measures:
  • 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 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 [ Time Frame: Day 30 ]
  • Technical Success of the procedure [ Time Frame: Day 0 ]

    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 [ Time Frame: Day 0-7 ]

Estimated Enrollment: 220
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331473

Contacts
Contact: Panagiotis Papanagiotou, MD +49684116 ext 24302 provenon.study@me.com
Contact: Christian Roth, MD +49684116 ext 24302 provenon.study@me.com

Locations
Germany
Department of Diagnostic and Interventional Neuroradiology Recruiting
Homburg, Saarland, Germany, 66424
Contact: Panagiotis Papanagiotou, MD    49684116 ext 24302    provenon.study@me.com   
Contact: Christian Roth, MD    49684116 ext 24302    provenon.study@me.com   
Principal Investigator: Wolfgang Reith, MD         
Sub-Investigator: Panagiotis Papanagiotou, MD         
Sub-Investigator: Christian Roth, MD         
Sponsors and Collaborators
Saarland University
Investigators
Principal Investigator: Wolfgang Reith, MD Saarland University Hospital
  More Information

Publications:
Responsible Party: Prof. Wolfgang Reith, Department of Diagnostic and Interventional Neuroradiology
ClinicalTrials.gov Identifier: NCT01331473     History of Changes
Other Study ID Numbers: PROVENON01
Study First Received: March 30, 2011
Last Updated: December 2, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Saarland University:
Carotid Artery
Stenting
CAS
proximal protection

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014