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Device: Ascyrus Medical Dissection Stent (AMDS)

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ClinicalTrials.gov Identifier: NCT03035643
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ascyrus Medical LLC.

Brief Summary:

This study is for participants who have been diagnosed with an acute aortic dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/ intramural hematoma). In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen). The blood is now flowing through both channels.

The purpose of this study is to investigate the feasibility and safety of the AMDS (stent). The use of this device may allow healing of the false lumen (separated channel). If the AMDS together with conventional surgery is effective, it is believed that this could lead to the repair of the dissection (tear) in the treated aorta,


Condition or disease Intervention/treatment Phase
Aortic Dissection Device: Ascyrus Medical Dissection Stent placement Not Applicable

Detailed Description:

Patients diagnosed with an acute aortic dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/ intramural hematoma) are being asked to take part in the DARTS study. The investigators are exploring the feasibility and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) involving the ascending aorta and aortic arch through open surgical repair.

In a healthy aorta (the vessel that supplies blood to most of your body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). In this case a tear has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen). The blood is now flowing through both channels.

Although the first segment of the aorta can be replaced, this conventional operation only treats the segment immediately above the heart. Because of the complexity of the patients medical condition and technical limitations, the remainder of the separated channel in the hard to reach area is normally left untreated.

Following this initial lifesaving surgery, the part of the separated channel that is not treatable by standard surgery may expand, weakening the wall of the aorta further which can cause rupture and death. To prevent this, 40-50% of patients require additional invasive surgeries. It is normal procedure for the cardiac surgeons to repair your tear by putting a graft in the first portion of the aorta immediately above the heart.

The investigators are examining a new device called the Ascyrus Medical Dissection Stent (AMDS) that works in conjunction with the standard operation and graft to treat the secondary channel in the hard to reach areas of the aorta.

The AMDS is a stent made of Teflon fabric sewn to a tubular Nitinol (nickel and titanium) stent. The stent is not covered with any cloth material and when placed in the aorta allows blood flow to the sides of the aorta. The stent is placed inside the aorta and allowed to expand to open up the aorta. It will help to reattach the separated layer of the aortic wall back to its original position. The safety of the AMDS and its function of closure of the false lumen will be the focus of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : February 21, 2022
Estimated Study Completion Date : February 21, 2022

Arm Intervention/treatment
Experimental: Ascyrus Medical Dissection Stent
Ascyrus Medical Dissection Stent placement
Device: Ascyrus Medical Dissection Stent placement
The study is a prospective, non-randomized, non-blinded, single-arm, single center study evaluating the feasibility and safety of this new design of stent. The device will be implanted during already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.




Primary Outcome Measures :
  1. Number of participants with treatment-related mortality. [ Time Frame: 4 weeks ]
    Primary safety outcome. The number of patients with mortality related to the treatment device.


Secondary Outcome Measures :
  1. Number of participants with treatment-related neurological deficit. [ Time Frame: 4 weeks ]
    Secondary safety outcome. The number of patients with neurological deficit related to the treatment device.

  2. Number of participants with false lumen exclusion within the treatment area confined by the treatment device. [ Time Frame: Immediate to long term (12-24 weeks) ]
    Primary efficacy outcome. Number of participants with false lumen exclusion within the treatment area confined by the treatment device.

  3. Assess need for stent removal. [ Time Frame: immediate to long term (12-24 weeks) ]
    Stent placement and retention. The number of patients requiring removal of the stent.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject must have one of the following diagnosed within 0-14 days:

  1. Acute DeBakey I dissection or
  2. Acute DeBakey I intramural hematoma (IMH)

Exclusion Criteria:

General Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

  1. Less than 18 years of age or over 80 years of age
  2. Life expectancy less than 2 years
  3. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  4. Unwilling to comply with the follow-up schedule
  5. Refusal to give informed consent

Medical Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

  1. Uncontrolled systemic infection
  2. Stroke or paralysis/ paraplegia in the last 30 days
  3. Uncontrollable anaphylaxis to iodinated contrast
  4. Known allergy(ies) to Nitinol and PTFE
  5. Patient in extreme hemodynamic compromise (requiring moderate to high doses of inotropic and vasopressor agents) and/or cardiopulmonary resuscitation (CPR)
  6. Inability to obtain CT angiograms for follow-up.
  7. Diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing at a date prior to the diagnosis of the dissection.

Anatomical Exclusion Criteria

  1. Any pathology of mycotic origin
  2. Subacute or chronic dissection (>14 days after the index event)
  3. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
  4. Extensive thrombus or calcifications in the aortic arch
  5. Excessive tortuosity precluding safe passage of the AMDS
  6. Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035643


Locations
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Canada, Alberta
Mazankowski Alberta Heart Institute, University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
London Health Sciences Center- University Hospital
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal Heart Institute
Montréal, Quebec, Canada, HIT 1C8
CHUM
Montréal, Quebec, Canada
Sponsors and Collaborators
Ascyrus Medical LLC.
Investigators
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Study Chair: Dr. Shahriari CEO

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Responsible Party: Ascyrus Medical LLC.
ClinicalTrials.gov Identifier: NCT03035643     History of Changes
Other Study ID Numbers: Pro00066039_AME3
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases