Carotid Filtration During Endovascular Aortic Valve Implantation

NCT01484249 | Completed DMC

• 1 other identifier: CMP 001b
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed as a First In Man (FIM) trial to evaluate the feasibility and technical capability of the Claret CE Pro System in delivering two embolic filters to the brachiocephalic artery and the left common carotid artery during a Transcatheter aortic valve implantation (TAVI) procedure in order to protect the neurovasculature from debris liberated during the procedure.

Conditions

Heart Diseases

Keywords

embolic; filters; brachiocephalic; neurovasculature; debris

Outcome Measures

Primary Outcomes (1)

• Primary endpoint is technical success of the CE Pro System to deliver, retrieve proximal & distal filters during an endovascular procedure such as Transcatheter aortic valve implantation (TAVI).

  Technical success defined as, successful delivery \& retrieval of the proximal \& distal filters. The following Operator feedback was collected \& used to evaluate the primary endpoint. Operators are asked to record, the indwelling time for the CE Pro System was used. Calculated as duration from the CE Pro System Insertion Start Time to Final Retrieval Stop Time. Operators are asked to rate the CE Pro Systems performance based on a scale of 1 to 5, with 5 being the highest rating.

  From the CE Pro System Insertion Start Time to Final Retrieval Stop Time

Secondary Outcomes (1)

• Transient Ischemia Attack (TIA) Rates

  30 day follow up

Interventions

CE Pro System DEVICE

The CE Pro System consists of a delivery catheter with an integrated proximal filter intended to be deployed in the brachiocephalic artery. In addition, the device has an articulating distal tip and a through lumen to allow a commercial intravascular filter to be back-loaded into the CE Pro System and be deployed into and retrieved from the left carotid artery.

Also known as: Gen 2.0, Gen 2.1, Gen 2.2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be scheduled to undergo an endovascular aortic valve prosthesis implant procedure with the femoral artery as the intended access site for the valve delivery system.
• Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure.
• Subject's left carotid artery and innominate artery diameters must be compatible with the Claret CE Pro System sizes available for the procedure (refer to package labeling for appropriate sizing information).
• Subject must have been informed of the nature of the study, agree to its provisions, and provide written informed consent.

You may not qualify if:

• Subject requires an emergent procedure.
• Subject has carotid artery stenosis \>70% in either carotid artery.
• Subject innominate or left carotid artery reveals significant stenosis, ectasia, dissection or aneurysm at the ostium or within 3 cm of the ostium.
• Subject has allergy to materials from which the device is constructed (Nitinol, fluorinated ethylene-propylene, polyamide, polyimide, platinum, iridium, stainless steel, cyanoacrylate adhesives, polycarbonate, polyethylene, polyester, polyurethane, PTFE \[poly-tetrafluoroethylene\], polydimethylsiloxane \[lubricant coating\], silicone, polyetheretherketone, tin-silver \[solder\] or acrylated urethane adhesives)
• Subject has a history of bleeding diatheses or coagulopathy or will refuse blood transfusion in cases of emergency.
• Subject has renal insufficiency, defined as a creatinine level \> 2.5 mg/dl at the time of treatment, unless subject is on chronic hemodialysis.
• Subject has hyperthyroidism.
• Subject suffered recent (within the past 3 months) stroke with permanent deficit.
• Subject suffered recent (within the past 6 months) significant gastrointestinal (GI) bleed.
• Subject is involved in another clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.
• Subject history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, Clopidogrel, or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.

Sponsors & Collaborators

• Claret Medical: lead
• Meditrial Europe Ltd.: collaborator

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Eberhard Grube, MD, Ph D

  Professor of Medicine, Medizinishce Klinik und Poliklinik II, Universitätsklinikum Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: December 2, 2011
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 5, 2011

Record last verified: 2011-12