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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01114724
First received: April 26, 2010
Last updated: July 28, 2014
Last verified: July 2014

April 26, 2010
July 28, 2014
May 2010
May 2013   (final data collection date for primary outcome measure)
All Cause Mortality. [ Time Frame: Up to 30 days after the stent graft implant. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01114724 on ClinicalTrials.gov Archive Site
  • All-cause Mortality [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Subjects With Successful Delivery and Deployment of the Device. [ Time Frame: At implant. ] [ Designated as safety issue: Yes ]
  • Subjects With Coverage of Primary Tear [ Time Frame: At implant ] [ Designated as safety issue: Yes ]
  • Aortic Rupture [ Time Frame: Within 30 days ] [ Designated as safety issue: Yes ]
  • Aortic Rupture [ Time Frame: Within 12 months ] [ Designated as safety issue: Yes ]
  • Subjects With Secondary Endovascular Procedures [ Time Frame: Through12 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Successful delivery and deployment of the device. [ Time Frame: At time of implant. ] [ Designated as safety issue: Yes ]
  • Change in the aorta. [ Time Frame: At 6 and 12 months. ] [ Designated as safety issue: Yes ]
  • The device covers the tear in the aorta. [ Time Frame: At implant through 60 months. ] [ Designated as safety issue: Yes ]
  • Secondary aortic repair [ Time Frame: Up to 60 months after the implant. ] [ Designated as safety issue: Yes ]
  • Device, procedure and/or aortic related serious adverse events. [ Time Frame: Up to 60 months after the implant. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Dissection
Device: Valiant Thoracic Stent Graft will the Captivia Delivery System
All subjects with be implanted with this device
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System
Intervention: Device: Valiant Thoracic Stent Graft will the Captivia Delivery System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
June 2017
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114724
IP # 118
Yes
Medtronic Endovascular
Medtronic Endovascular
Medtronic
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
Medtronic Endovascular
July 2014

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