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Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device. (DESERVE)
This study is currently recruiting participants.
Verified by Invatec S.p.A., November 2008
First Received: November 25, 2008   Last Updated: June 4, 2009   History of Changes
Sponsored by: Invatec S.p.A.
Information provided by: Invatec S.p.A.
ClinicalTrials.gov Identifier: NCT00798512
  Purpose

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
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.

Resource links provided by NLM:


Further study details as provided by Invatec S.p.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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
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.
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).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798512

Contacts
Contact: Mario Landini mario.landini@invatec.com
Contact: Elena Ravanelli elena.ravanelli@invatec.com

Locations
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            
Sponsors and Collaborators
Invatec S.p.A.
Investigators
Study Chair: Giancarlo Biamino, MD Gruppo Villa Maria - Endovascular Villa Maria Cecilia Hospital
  More Information

No publications provided

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

Keywords provided by Invatec S.p.A.:
carotid artery stenting
cerebral protection
stroke
ischemic lesion
DW-MRI

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Diseases
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on September 10, 2009