Clinical trial NCT03397251: DARTS I: Feasibility, Safety, and Performance Trial
Official title: Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute DeBakey I Aortic Dissection
Intramural Hematoma
Lead sponsor: Artivion Inc.
Sponsor class: INDUSTRY
Collaborators: name: Artivion Inc.
First posted: 2018-01-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate 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.

Detailed description: AMDS is designed to complement the replacement of the ascending aorta with conventional surgical technique utilizing a conventional polyester graft. AMDS is constructed of an uncovered Nitinol wire braided stent attached proximally to a polytetrafluoroethylene (PTFE) felt graft component. The PFTE felt graft component excludes the FL at the distal aortic anastomosis and the wire stent re-expands the dissection flap within the arch and descending aorta, which aims to treat malperfusion and promote positive remodeling of the aorta.

The DARTS I Feasibility, Safety and Performance trial is a prospective, non-randomized, non-blinded, single-arm, multi-institutional Canadian study evaluating the feasibility and safety of the AMDS graft. A goal of 30 subjects will be enrolled at 1 site in Germany.

The enrollment period will span a minimum of 3 months from Institutional Review Board (IRB) approval and site activation. Candidates for this study are adults who require repair of an acute DeBakey type I aorta dissection and/or intramural hematoma (IMH). Patients will be consented pre-operatively and enrolled patients will be followed for approximately 5 years after their AMDS implantation date. Data will be collected at 10 time points: baseline (pre-operatively), discharge, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively, 1 year post-operatively and thereafter, annually, for a total of 5 years.

Eligibility criteria: Inclusion Criteria:

1. Informed Consent obtained
2. ≥18 years of age or ≤80 years of age (male or female)

   Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
3. Acute DeBakey I dissection or
4. 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
6. Institutionalized individualized due to administrative or judicial order
7. Individuals with a dependent relationship to the sponsor or investigator

Medical Exclusion Criteria

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

1. Uncontrolled systemic infection
2. Uncontrollable anaphylaxis to iodinated contrast
3. Known allergy(ies) to Nitinol and/or PTFE
4. Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
5. Inability to obtain CT angiograms for follow-up
6. Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of the dissection

Anatomical Exclusion Criteria

1. Any pathology of mycotic origin
2. Subacute or chronic dissection of the ascending aorta and aortic arch (\>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 as defined by CT angiography
5. Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
6. Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring \> 45mm in diameter
7. Aortic arch aneurysm \> 45mm in diameter

Primary outcomes:
measure: Number of participants with treatment-related mortality
timeFrame: 12 weeks
measure: Number of participants with treatment-related neurological deficit
timeFrame: 12 weeks
measure: Number of patients with aortic injury associated with the implantation of the device
timeFrame: 12 weeks
measure: Aortic arch branch vessel patency
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with treatment-related mortality
timeFrame: 24 weeks and 12 months
measure: Number of participants with treatment-related neurological deficit
timeFrame: 24 weeks and 12 months
measure: Number of patients with aortic injury associated with the implantation of the device
timeFrame: 24 weeks and 12 months
measure: Aortic arch branch vessel patency
timeFrame: 24 weeks and 12 months
Other outcomes:
measure: Re-expansion of the true lumen
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: False lumen reattachment/positive remodeling
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: False Lumen Thrombosis
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: Stent-graft integrity Assessment
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: Successful device deployment
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: AMDS removal
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: AMDS related re-interventions after the dissection repair
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: Cardiopulmonary bypass (CBP) duration
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: Circulatory arrest duration
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: Time in ICU
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: Duration of hospitalization
timeFrame: 12 weeks, 24 weeks, and 12 months
measure: AMDS procedure duration
timeFrame: 12 weeks, 24 weeks, and 12 months
Locations:
city: Berlin
country: Germany
facility: Deutsches Hertzzentrum Berlin
Study officials:
affiliation: German Heart Institute
name: Jorg Kempfert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montagner M, Kofler M, Heck R, Buz S, Starck C, Kurz S, Falk V, Kempfert J. Initial experience with the new type A arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):276-283. doi: 10.1093/icvts/ivab085.
citation: Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Moon MC. Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. Ann Thorac Surg. 2021 Feb;111(2):463-470. doi: 10.1016/j.athoracsur.2020.05.090. Epub 2020 Jul 13.
citation: Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Shahriari A, Moon MC. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Ann Thorac Surg. 2019 Dec;108(6):1768-1775. doi: 10.1016/j.athoracsur.2019.04.121. Epub 2019 Jun 27.