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Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

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: NCT01114724
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : July 3, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

Condition or disease Intervention/treatment Phase
Aortic Dissection Device: Valiant Thoracic Stent Graft with the Captivia Delivery System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valiant® Thoracic Stent Graft With the Captivia Delivery System. Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device




Primary Outcome Measures :
  1. All Cause Mortality. [ Time Frame: Up to 30 days after the stent graft implant. ]

Secondary Outcome Measures :
  1. All-cause Mortality [ Time Frame: at 12 months ]
  2. Subjects With Successful Delivery and Deployment of the Device. [ Time Frame: At implant. ]
  3. Subjects With Coverage of Primary Tear [ Time Frame: At implant ]
  4. Aortic Rupture [ Time Frame: Within 30 days ]
  5. Aortic Rupture [ Time Frame: Within 12 months ]
  6. Subjects With Secondary Endovascular Procedures [ Time Frame: Through12 months ]
  7. Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment [ Time Frame: At 6 months ]
  8. Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment [ Time Frame: At 12 months ]
  9. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 6 months ]
  10. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 12 months ]
  11. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 6 months ]
  12. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 12 months ]
  13. Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [ Time Frame: at 30 days ]
  14. Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [ Time Frame: at 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria

  • Subject signed an informed consent.
  • Subject is at least 18 years old.
  • Subject has an acute, complicated Type B aortic dissection with evidence of at least one of the following:
  • Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia)
  • Visceral ischemia measured by either radiographic or clinical evidence.
  • Renal ischemia measured by either radiographic or clinical evidence.
  • Spinal cord ischemia measured by either radiographic or clinical evidence.
  • Lower limb ischemia measured by either radiographic or clinical evidence.
  • Rupture - Measured by radiographic or clinical evidence.
  • Subject is hemodynamically stable.
  • Subject's anatomy must meet all of the following anatomical criteria:

Proximal landing zone aortic diameter must be between 20 mm and 44 mm;

  • Centerline distance from distal margin of left CCA or in cases of bovine anatomy, innominate artery, to start of most proximal tear must be ≥ 20 mm;
  • Subject has patent iliac or femoral arteries or can tolerate an iliac conduit that allows endovascular access to the dissection site with the delivery system of the appropriate sized device.
  • Thoracic aortic dissection is confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) with 3-D reconstruction, and/or contrast enhanced magnetic resonance angiogram (MRA) obtained prior to the implant procedure.

Exclusion Criteria

  • Planned placement of the COVERED portion of the stent graft over the left carotid artery, or the celiac trunk.
  • Subject has systemic infection.
  • Subject is pregnant.
  • Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
  • Subject has had a cerebral vascular accident (CVA) within 2 months.
  • Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
  • Subject has a history of Marfan Syndrome or other connective tissue disorder.
  • Subject is currently participating in an investigational drug or device clinical trial which would interfere with the endpoints and follow-ups of this study.
  • Subject has a known allergy or intolerance to the device components.
  • Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  • Subject has a co-morbidity causing expected survival to be less than 1 year.

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): NCT01114724


Locations
Show Show 17 study locations
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
Investigators
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Principal Investigator: Joseph E. Bavaria, M.D. Univ. of Pennsylvania Health System
Principal Investigator: W. Anthony Lee, M.D., F.A.C.S Lynn Heart Institute, Boca Raton Community Hospital
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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01114724    
Other Study ID Numbers: IP # 118
First Posted: May 3, 2010    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: May 30, 2018
Last Verified: January 2018
Keywords provided by Medtronic Endovascular:
Thoracic dissection
Endovascular aortic repair
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases