Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.

Carotid Artery Disease Clinical Trial

— DESERVE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798512
• Other study ID #: N999
• Status: Completed
• Phase: N/A
• First received: November 25, 2008
• Last updated: March 14, 2016
• Start date: February 2008
• Est. completion date: March 2011

Study information

• Verified date: March 2016
• Source: Invatec S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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 protection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Stroke Prevention

Intervention

Device:
• Carotid artery stenting
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).

Locations

Country	Name	City	State
Germany	CardioVascular Center Frankfurt, Sankt Katharinen	Frankfurt
Germany	Heart Center Leipzig, Clinical and Interventional Angiology	Leipzig
Italy	Gruppo Villa Maria, Villa Maria Cecilia Hospital	Cotignola	RA
Italy	Casa di Cura Privata "Montevergine" S.p.A.	Mercogliano	Avellino
Italy	Ospedale Civile di Mirano, Unità di Cardiologia	Mirano
Poland	Jagellonian University, College of Medicine, Institute of Cardiology, University Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Invatec S.p.A.

Countries where clinical trial is conducted

Germany,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		3-12 hours after index procedure	Yes
Secondary	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.		30 days	Yes