Clinical trial NCT00798512: Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Disease
Stroke Prevention
Keywords: carotid artery stenting
cerebral protection
stroke
ischemic lesion
DW-MRI
Lead sponsor: Invatec S.p.A.
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 protection.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old;
2. Eligibility for carotid artery revascularization;
3. 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.
4. Suitable clinical conditions to perform DW-MRI.
5. Written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Female with childbearing potential without a negative pregnancy test.
2. Life-expectancy less than 6 months.
3. Underlying disease of the carotid artery other than atherosclerosis (e.g. vasculitis, traumatic dissection, fibromuscular dysplasia).
4. Prior stenting in the target vessel;
5. Patients with chronic or re-current atrial fibrillation.
6. Patient has had a Myocardial Infarction within 72 hours prior to the procedure.
7. Patient experienced a stroke within 4 weeks prior to the procedure.
8. History of severe disabling stroke according to the modified Rankin scale \> 4.
9. Severe renal failure (serum creatinine \> 2.0 mg/dL).
10. Severe peripheral arterial occlusive disease, which might impede a safe introduction of a 9F-sheath for the use of a Mo.Ma-device.
11. Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Statins, Heparin, Nitinol, contrast agents (that cannot be adequately pre-medicated).
12. 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.
13. Any planned major surgery within 30 days after the study procedure.
14. 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:
15. Totally occluded internal carotid artery considered as the target vessel.
16. Multiple internal carotid artery stenoses or lesion longer than 4 cm (whichever occurs) that cannot be covered by one (1) stent.
17. Severe ostial stenosis of the common carotid artery.
18. The presence of ipsilateral intracranial stenosis that requires treatment.
19. Contralateral occlusion of the internal carotid arteries associated with a poor collateral flow through the circle of Willis.
20. 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.

Primary outcomes:
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).
timeFrame: 3-12 hours after index procedure
Secondary outcomes:
measure: 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.
timeFrame: 30 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt, Sankt Katharinen
city: Leipzig
country: Germany
facility: Heart Center Leipzig, Clinical and Interventional Angiology
city: Mercogliano
country: Italy
facility: Casa di Cura Privata "Montevergine" S.p.A.
state: Avellino
city: Cotignola
country: Italy
facility: Gruppo Villa Maria, Villa Maria Cecilia Hospital
state: RA
city: Mirano
country: Italy
facility: Ospedale Civile di Mirano, Unità di Cardiologia
city: Krakow
country: Poland
facility: Jagellonian University, College of Medicine, Institute of Cardiology, University Hospital
Study officials:
affiliation: Gruppo Villa Maria - Endovascular Villa Maria Cecilia Hospital
name: Giancarlo Biamino, MD
role: STUDY_CHAIR
References: