PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

Carotid Artery Stenosis Clinical Trial

— PROVENON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01331473
• Other study ID #: PROVENON01
• Status: Recruiting
• Phase: Phase 3
• First received: March 30, 2011
• Last updated: December 2, 2011
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2011
• Source: Saarland University
• Contact: Panagiotis Papanagiotou, MD
• Phone: +49684116
• Email: provenon.study[@]me.com
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Procedure:
• Carotid Artery Stenting with Proximal Protection
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
• Carotid Artery Stenting without Protection
Carotid artery angioplasty and stenting without cerebral embolic protection

Locations

Country	Name	City	State
Germany	Department of Diagnostic and Interventional Neuroradiology	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Grunwald IQ, Papanagiotou P, Roth C, Fassbender K, Karp K, Krick C, Schieber H, Müller 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. — View 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. Epub 2007 Jan 5. — View Citation

Kastrup A, Nägele T, Gröschel 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. Epub 2006 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging		Day 1-3
Secondary	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
Secondary	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
Secondary	Access site vascular complications, defined as need for surgical repair or blood transfusion		Day 0-7