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Sponsored by: |
Invatec S.p.A. |
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Information provided by: | Invatec S.p.A. |
ClinicalTrials.gov Identifier: | NCT00798512 |
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.
Condition | Intervention |
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Carotid Artery Disease Stroke Prevention |
Device: Carotid artery stenting |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy 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. |
Estimated Enrollment: | 120 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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). |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
Contact: Mario Landini | mario.landini@invatec.com | |
Contact: Elena Ravanelli | elena.ravanelli@invatec.com |
Germany | |
CardioVascular Center Frankfurt, Sankt Katharinen | Recruiting |
Frankfurt, Germany, 60389 | |
Contact: Horst Sievert | |
Principal Investigator: Horst Sievert, MD | |
Heart Center Leipzig, Clinical and Interventional Angiology | Not yet recruiting |
Leipzig, Germany, 04289 | |
Contact: Dierk Scheinert | |
Principal Investigator: Dierk Scheinert, MD | |
Italy | |
Ospedale Civile di Mirano, Unità di Cardiologia | Recruiting |
Mirano, Italy, 30035 | |
Contact: Bernard Reimers | |
Principal Investigator: Bernard Reimers, MD | |
Italy, Avellino | |
Casa di Cura Privata "Montevergine" S.p.A. | Recruiting |
Mercogliano, Avellino, Italy, 83013 | |
Contact: Paolo Rubino, MD | |
Principal Investigator: Paolo Rubino, MD | |
Italy, RA | |
Gruppo Villa Maria, Villa Maria Cecilia Hospital | Recruiting |
Cotignola, RA, Italy, 48010 | |
Contact: Alberto Cremonesi | |
Principal Investigator: Alberto Cremonesi, MD | |
Poland | |
Jagellonian University, College of Medicine, Institute of Cardiology, University Hospital | Recruiting |
Krakow, Poland, 31-501 | |
Contact: Dariusz Dudek | |
Principal Investigator: Dariusz Dudek, MD |
Study Chair: | Giancarlo Biamino, MD | Gruppo Villa Maria - Endovascular Villa Maria Cecilia Hospital |
Responsible Party: | Invatec S.p.A. ( Mario Landini ) |
Study ID Numbers: | N999 |
Study First Received: | November 25, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00798512 History of Changes |
Health Authority: | Italy: Ministry of Health |
carotid artery stenting cerebral protection stroke ischemic lesion DW-MRI |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Ischemia Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Nervous System Diseases Vascular Diseases Central Nervous System Diseases Cardiovascular Diseases |
Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |