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Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial (DARTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03397251
Recruitment Status : Active, not recruiting
First Posted : January 11, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ascyrus Medical LLC.

Tracking Information
First Submitted Date  ICMJE January 6, 2018
First Posted Date  ICMJE January 11, 2018
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE March 7, 2018
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2018)
  • Number of participants with treatment-related mortality. [ Time Frame: 12 weeks ]
    Primary safety outcome. The number of patients with mortality related to the treatment device.
  • Number of participants with treatment-related neurological deficit. [ Time Frame: 12 weeks ]
    Primary safety outcome. The number of patients with neurological complications related to the treatment device.
  • Number of patients with aortic injury associated with the implantation of the device. [ Time Frame: 12 weeks ]
    Primary safety outcome. The number of patients with aortic injury related to the treatment device.
  • Aortic arch branch vessel patency. [ Time Frame: 12 weeks ]
    Primary safety outcome. The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device.
  • Number of participants with treatment-related mortality. [ Time Frame: 24 weeks ]
    Secondary safety outcome. The number of patients with mortality related to the treatment device.
  • Number of participants with treatment-related neurological deficit. [ Time Frame: 24 weeks ]
    Secondary safety outcome. The number of patients with neurological complications related to the treatment device.
  • Number of patients with aortic injury associated with the implantation of the device. [ Time Frame: 24 weeks ]
    Secondary safety outcome. The number of patients with aortic injury related to the treatment device.
  • Aortic arch branch vessel patency. [ Time Frame: 24 weeks ]
    Secondary safety outcome. The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
Official Title  ICMJE Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Acute DeBakey I Aortic Dissection
  • Acute Aortic Dissection
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Ascyrus Medical Dissection Stent
Ascyrus Medical Dissection Stent placement
Intervention: Device: Ascyrus Medical Dissection Stent placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 11, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2018)
30
Estimated Study Completion Date  ICMJE January 15, 2023
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03397251
Other Study ID Numbers  ICMJE DARTS-AMDS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ascyrus Medical LLC.
Study Sponsor  ICMJE Ascyrus Medical LLC.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ali Shahriari, MD
PRS Account Ascyrus Medical LLC.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP