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Heart DiseasesNCT01484249

Carotid Filtration During Endovascular Aortic Valve Implantation

A study testing CE Pro System in people with Heart Diseases, run by Claret Medical.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Diseases
What is being tested?
CE Pro System
Type of treatment
Medical device
How many people
38 participants
Where
No sites listed yet
Study dates
Feb 2010to May 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

About this study

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.

Read the detailed description

Transcatheter aortic valve implantation (TAVI) is a recently developed procedure whereby a prosthetic aortic valve is implanted percutaneously, and the procedure has demonstrated promising results in high risk surgical populations.

TAVI currently requires the use of large bore (18-26F) catheter delivery systems that are often difficult to deliver to over the aortic arch to the aortic annulus. Available data indicate that TAVI is associated with a 4-12% procedural stroke rate and approximately 10% procedural mortality. It has been suggested that these strokes are most likely caused by the liberation of embolic debris either when the TAVI delivery catheter is advanced over the aortic arch or during the actual valve deployment. Given this situation, the availability of devices able to protect both hemispheres of the brain from potentially embolic debris during the TAVI procedure is an emerging clinical need.

Claret Medical has developed a technology to provide protection to the neurovascular system during TAVI and other valve repair procedures.

Conditions
Heart Diseases
Being tested
CE Pro System
Keywords
embolic, filters, brachiocephalic, neurovasculature, debris
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CE Pro SystemDevice

    Also called Gen 2.0, Gen 2.1, Gen 2.2

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. Transient Ischemia Attack (TIA) Rates

    The secondary endpoints for this trial are safety endpoints and are presented as adverse events.

    Measured: 30 day follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study startFeb 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484249
Sponsor's protocol ID
CMP 001b
Status last verified
Dec 2011
First submitted
24 Nov 2011
Last updated
5 Dec 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing CE Pro System in people with Heart Diseases, run by Claret Medical.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: From the CE Pro System Insertion Start Time to Final Retrieval Stop Time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01484249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011.

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