Carotid Artery DiseaseDESERVENCT00798512
Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.
A study testing Carotid artery stenting in people with Carotid Artery Disease and Stroke Prevention, run by Invatec S.p.A. at 6 sites in 3 countries.
Trial summary
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow blockage (Mo.Ma device) for cerebral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease, Stroke Prevention
- What is being tested?
- Carotid artery stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Feb 2008to Mar 2011
- Phase
- Interventional
- 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
- ≥ 18 years old;
- Eligibility for carotid artery revascularization;
- A significant stenosis in symptomatic patients with ≥ 50% Diameter Stenosis (%DS) or asymptomatic ≥ 80 %DS as defined by angiography.
- Symptomatic is defined as a carotid artery stenosis associated with ipsilateral TIA, amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
- Suitable clinical conditions to perform DW-MRI.
- Written informed consent as approved by the Ethics Committee of the respective clinical site.
Who cannot join
- Female with childbearing potential without a negative pregnancy test.
- Life-expectancy less than 6 months.
- Underlying disease of the carotid artery other than atherosclerosis (e.g. vasculitis, traumatic dissection, fibromuscular dysplasia).
- Prior stenting in the target vessel;
- Patients with chronic or re-current atrial fibrillation.
- Patient has had a Myocardial Infarction within 72 hours prior to the procedure.
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- Patient experienced a stroke within 4 weeks prior to the procedure.
- History of severe disabling stroke according to the modified Rankin scale > 4.
- Severe renal failure (serum creatinine > 2.0 mg/dL).
- Severe peripheral arterial occlusive disease, which might impede a safe introduction of a 9F-sheath for the use of a Mo.Ma-device.
- Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Statins, Heparin, Nitinol, contrast agents (that cannot be adequately pre-medicated).
- Patient currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the DESERVE study endpoints.
- Any planned major surgery within 30 days after the study procedure.
- In the investigators opinion patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.
- Angiographic exclusion criteria:
- Totally occluded internal carotid artery considered as the target vessel.
- Multiple internal carotid artery stenoses or lesion longer than 4 cm (whichever occurs) that cannot be covered by one (1) stent.
- Severe ostial stenosis of the common carotid artery.
- The presence of ipsilateral intracranial stenosis that requires treatment.
- Contralateral occlusion of the internal carotid arteries associated with a poor collateral flow through the circle of Willis.
- An aortic arch anatomical complexity that may preclude the safe placement of the Mo.Ma device including particularly, the impossibility to navigate a stiff guide wire into the external carotid artery.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Italy3 sites
Gruppo Villa Maria, Villa Maria Cecilia Hospital
Cotignola, RA, 48010
Casa di Cura Privata "Montevergine" S.p.A.
Mercogliano, Avellino, 83013
Ospedale Civile di Mirano, Unità di Cardiologia
Mirano, 30035
Germany2 sites
CardioVascular Center Frankfurt, Sankt Katharinen
Frankfurt, 60389
Heart Center Leipzig, Clinical and Interventional Angiology
Leipzig, 04289
Poland1 site
Jagellonian University, College of Medicine, Institute of Cardiology, University Hospital
Krakow, 31-501
About this study
Official title: DESERVE: Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device. A Prospective, Multicenter Study.
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow blockage (Mo.Ma device) for cerebral protection.
- Conditions
- Carotid Artery Disease, Stroke Prevention
- Being tested
- Carotid artery stenting
- Keywords
- carotid artery stenting, cerebral protection, stroke, ischemic lesion, DW-MRI
- Medical subject headings
- Carotid Artery Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid artery stentingDevice
The MO.MA is a cerebral protection catheter based on the proximal flow blockage concept which is achieved by endovascular clamping of Common Carotid Artery (CCA) and External Carotid Artery (ECA). The MO.MA proximal flow blockage cerebral protection device is indicated to be used in patients eligible for carotid angioplasty and/or the carotid bifurcation and is aimed to prevent brain embolism during the stenting procedure.
For the purpose of this study the Cristallo Ideale™ Carotid Stent System (Invatec S.R.L. Roncadelle, Italy) will be exclusively used. Cristallo Ideale™ consists of a carotid dedicated self-expanding stent pre-mounted on a rapid exchange delivery catheter. The stent platform is made of a Nitinol alloy and characterized by a hybrid design with closed cell in the central zone and open cell in both end zones (proximal and distal).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single arm Study in which 120 patients fulfilling eligibility criteria will be screened and undergo carotid stenting with the Cristallo ideale™ carotid stent after placement of the Mo.Ma device as cerebral protection system. The technique of diffusion-weighted magnetic resonance imaging (DW-MRI) will be used to identify new ischemic lesions. Receives: Device: Carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The de-novo occurrence of intra-cerebral lesions per patient by comparing baseline (within 1 week prior procedure) and post-procedural DW-MRI (from 3 to 12 hours post procedure).
Measured: 3-12 hours after index procedure
Secondary outcomes (1)
Device Success; Technical Success; Procedural Success; Restenosis rate at 30 days follow up; TLR at 30 days follow up; Access Site Complications; MACCE at 30 days; Incidence of TIA up to 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invatec S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giancarlo Biamino, MD, Study chair, Gruppo Villa Maria - Endovascular Villa Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798512
- Sponsor's protocol ID
- N999
- Acronym
- DESERVE
- Status last verified
- Mar 2016
- First submitted
- 25 Nov 2008
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESERVE: Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device. A Prospective, Multicenter Study.
- ClinicalTrials.gov ID
- NCT00798512
- Acronym / sponsor ID
- DESERVE / N999
- Conditions
- Carotid Artery Disease, Stroke Prevention
- Keywords
- carotid artery stenting, cerebral protection, stroke, ischemic lesion, DW-MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Invatec S.p.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Nov 2008 (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.
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow blockage (Mo.Ma device) for cerebral protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Carotid artery stentingSingle arm Study in which 120 patients fulfilling eligibility criteria will be screened and undergo carotid stenting with the Cristallo ideale™ carotid stent after placement of the Mo.Ma device as cerebral protection system. The technique of diffusion-weighted magnetic resonance imaging (DW-MRI) will be used to identify new ischemic lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years old;
- Eligibility for carotid artery revascularization;
- A significant stenosis in symptomatic patients with ≥ 50% Diameter Stenosis (%DS) or asymptomatic ≥ 80 %DS as defined by angiography.
- Symptomatic is defined as a carotid artery stenosis associated with ipsilateral TIA, amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
- Suitable clinical conditions to perform DW-MRI.
Key exclusion criteria (21 listed)
- Female with childbearing potential without a negative pregnancy test.
- Life-expectancy less than 6 months.
- Underlying disease of the carotid artery other than atherosclerosis (e.g. vasculitis, traumatic dissection, fibromuscular dysplasia).
- Prior stenting in the target vessel;
- Patients with chronic or re-current atrial fibrillation.
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 stentingThe MO.MA is a cerebral protection catheter based on the proximal flow blockage concept which is achieved by endovascular clamping of Common Carotid Artery (CCA) and External Carotid Artery (ECA). The MO.MA proximal flow blockage cerebral protection device is indicated to be used in patients eligible for carotid angioplasty and/or the carotid bifurcation and is aimed to prevent brain embolism during the stenting procedure. For the purpose of this study the Cristallo Ideale™ Carotid Stent System (Invatec S.R.L. Roncadelle, Italy) will be exclusively used. Cristallo Ideale™ consists of a carotid dedicated self-expanding stent pre-mounted on a rapid exchange delivery catheter. The stent platform is made of a Nitinol alloy and characterized by a hybrid design with closed cell in the central zone and open cell in both end zones (proximal and distal). | Device | 1 |
Primary outcome
The de-novo occurrence of intra-cerebral lesions per patient by comparing baseline (within 1 week prior procedure) and post-procedural DW-MRI (from 3 to 12 hours post procedure).
Time frame: 3-12 hours after index procedure
1 secondary outcome
Device Success; Technical Success; Procedural Success; Restenosis rate at 30 days follow up; TLR at 30 days follow up; Access Site Complications; MACCE at 30 days; Incidence of TIA up to 30 days.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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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.
Giancarlo Biamino, MD study chair
Gruppo Villa Maria - Endovascular Villa Maria Cecilia Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid artery stenting in people with Carotid Artery Disease and Stroke Prevention, run by Invatec S.p.A. at 6 sites in 3 countries.
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 6 inclusion and 21 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: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Germany, Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The de-novo occurrence of intra-cerebral lesions per patient by comparing baseline (within 1 week prior procedure) and post-procedural DW-MRI (from 3 to 12 hours post procedure). (time frame: 3-12 hours after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2016.