Carotid Artery StenosisPhase 3PROVENONNCT01331473
PROximal Protection VErsus NON-Protection in Carotid Artery Stenting
A Phase 3 study testing Carotid Artery Stenting with Proximal Protection and Carotid Artery Stenting without Protection in people with Carotid Artery Stenosis, run by Universität des Saarlandes at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid Artery Stenting with Proximal Protection and Carotid Artery Stenting without Protection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Diagnostic and Interventional Neuroradiology
Homburg, Saarland, 66424
Panagiotis Papanagiotou, MD, 49684116 ext. 24302, provenon.study@me.com
Christian Roth, MD, 49684116 ext. 24302, provenon.study@me.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid Artery Stenting with Proximal Protection, Carotid Artery Stenting without Protection
- Keywords
- Carotid Artery, Stenting, CAS, proximal protection
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery Stenting with Proximal ProtectionProcedure or surgery
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
Carotid Artery Stenting without ProtectionProcedure or surgery
Carotid artery angioplasty and stenting without cerebral embolic protection
| Study group | Role | What they receive |
|---|---|---|
| Carotid Artery Stenting without Protection | Active comparator | Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device Receives: Procedure: Carotid Artery Stenting without Protection |
| Carotid Artery Stenting with Proximal Protection | Active comparator | 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 Receives: Procedure: Carotid Artery Stenting with Proximal Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging
Measured: Day 1-3
Secondary outcomes (3)
Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
Measured: 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.
Measured: Day 0
Access site vascular complications, defined as need for surgical repair or blood transfusion
Measured: Day 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang Reith, MD, Principal investigator, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331473
- Sponsor's protocol ID
- PROVENON01
- Acronym
- PROVENON
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19198823Grunwald 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.
PubMed 17205314Kastrup 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.
PubMed 16888277
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.
- ClinicalTrials.gov ID
- NCT01331473
- Acronym / sponsor ID
- PROVENON / PROVENON01
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid Artery, Stenting, CAS, proximal protection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid Artery Stenting without Protection | Active comparator | Procedure: Carotid Artery Stenting without ProtectionSubjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device |
| Carotid Artery Stenting with Proximal Protection | Active comparator | Procedure: Carotid Artery Stenting with Proximal ProtectionSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Artery Stenting with Proximal ProtectionCarotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System | Procedure or surgery | Carotid Artery Stenting with Proximal Protection |
| Carotid Artery Stenting without ProtectionCarotid artery angioplasty and stenting without cerebral embolic protection | Procedure or surgery | Carotid Artery Stenting without Protection |
Primary outcome
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging
Time frame: Day 1-3
3 secondary outcomes
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
Access site vascular complications, defined as need for surgical repair or blood transfusion
Time frame: Day 0-7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
- Background: PubMed 19198823Grunwald 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.
- Background: PubMed 17205314Grunwald 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.
- Background: PubMed 16888277Kastrup 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Reith, MD principal investigator
Saarland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carotid Artery Stenting with Proximal Protection and Carotid Artery Stenting without Protection in people with Carotid Artery Stenosis, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panagiotis Papanagiotou, MD (+49684116 ext. 24302, provenon.study@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging (time frame: Day 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331473, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011.