Trial record 2 of 2649 for:
AMDS
PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection (PERSEVERE)
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| ClinicalTrials.gov Identifier: NCT05174767 |
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Recruitment Status :
Recruiting
First Posted : January 3, 2022
Last Update Posted : February 21, 2023
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Sponsor:
Artivion Inc.
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Artivion Inc.
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Brief Summary:
Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Aortic Dissection | Device: AMDS | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 93 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE |
| Actual Study Start Date : | May 27, 2022 |
| Estimated Primary Completion Date : | March 2024 |
| Estimated Study Completion Date : | March 2028 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Acute DeBakey Type I Dissection
In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use.
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Device: AMDS
AMDS Implantation |
Primary Outcome Measures :
- Primary Endpoint to Assess Incidence of Major Adverse Events [ Time Frame: Through 30 days ]
Patients experiencing at least one of the following MAEs:
- All-cause mortality (ACM)
- New disabling stroke
- New onset renal failure requiring dialysis
- Myocardial infarction (MI)
- Primary Endpoint to Assess Change in Maximal True Lumen (TL) diameter [ Time Frame: At 1 year ]
Patients with clinically meaningful (≥ 6.0 mm) true lumen expansion (at 1-Year), as defined by:
Change in maximal true lumen (TL) diameter in the aortic arch at Zone 3 (2 cm distal to the origin of the left subclavian artery) from pre-operative computed tomography angiogram (CTA) measurements on admission to 1-year CTA measurements without need for device-related aortic reintervention.
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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:
- ≥18 years of age or ≤80 years of age (male or female) at time of surgery
- Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event
- Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)
Exclusion Criteria:
- Other medical condition that is associated with limited life expectancy <2 years (e.g., cancer, congestive heart failure)
- Pregnant or breastfeeding.
- Unwilling to comply with the follow-up schedule
- Institutionalized due to administrative or judicial order
- Unwilling to accept blood transfusions for any reason
- Coronary malperfusion
- In circulatory shock (i.e., systolic blood pressure <90 mmHg) at time of screening
- In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at time of screening
- Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis)
- Clinical or radiographic signs of bowel infarction or gastrointestinal hemorrhage
- Base deficit > -10 mmol/L or -10 mEq/L
- American Society of Anesthesiologists risk class V (i.e., moribund patient not expected to live 24 hours with or without operation) or class VI (a declared brain dead patient whose organs are being removed for donor purposes)
- Previous placement of a thoracic endovascular graft
- Interventional and/or open surgical procedures 30 days prior to the dissection repair
- Planned major interventional and/or open surgical procedures 30 days post the dissection repair
- Systemic infection
- Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinated contrast but not anaphylaxis may be eligible with appropriate pre-medication, as deemed suitable by the Investigator)
- Known allergy(ies) to nitinol and/or polytetrafluoroethylene
- Inability to obtain CT angiograms for follow-up
- Previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, or Loeys-Dietz syndrome based on laboratory genetic testing
- Diagnosed with acute myocardial infarction in the 30 days prior to the dissection diagnosis
- Diagnosed with severe and catastrophic neurological complications in the 30 days prior to the dissection diagnosis (namely, obtundation or coma)
- Current Stage 5 end stage chronic kidney disease (eGFR ≤ 15 mL/min)
- History of bleeding disorder (i.e. hemophilia)
- A primary entry tear that extends into the arch or distal to the left subclavian artery
- Need for a total aortic arch replacement and/or repair, or reconstruction, of any part of the arch, and branch vessels (including extra-anatomic bypass of the branch vessels), for any reason as deemed necessary by the Investigator
- Any pathology of mycotic origin
- Aortic fistulous communication with non-vascular structure (e.g., esophagus, bronchial)
- Extensive thrombus or calcifications in the aortic arch, as defined by CTA
- Excessive tortuosity precluding safe passage of the AMDS, as defined by CTA
- Descending thoracic aneurysm involving the proximal third (one-third) of the descending aorta and measuring >45 mm in diameter
- Aortic arch aneurysm >50 mm 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): NCT05174767
Contacts
| Contact: Erin Adams, BSc, MSPH | (770) 419-3355 | erin.adams@artivion.com | |
| Contact: PERSEVERE Study Team | PERSEVERE@artivion.com |
Locations
Show 20 study locations
Sponsors and Collaborators
Artivion Inc.
Syneos Health
Investigators
| Principal Investigator: | Wilson Szeto, MD | University of Pennsylvania |
| Responsible Party: | Artivion Inc. |
| ClinicalTrials.gov Identifier: | NCT05174767 |
| Other Study ID Numbers: |
AMDS2101.000-C (02/21) |
| First Posted: | January 3, 2022 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Artivion Inc.:
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Aortic Diseases Cardiovascular Diseases Aortic Dissection Aortic Remodeling |
Malperfusion Acute Acute Aortic Dissection |
Additional relevant MeSH terms:
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Aortic Dissection Dissection, Blood Vessel Aneurysm Vascular Diseases |
Cardiovascular Diseases Acute Aortic Syndrome Aortic Diseases |