Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

Type B Aortic Dissection Clinical Trial

Official title:

Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908388
• Other study ID #: TAG 08-01
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: September 26, 2017
• Start date: October 2009
• Est. completion date: February 28, 2017

Study information

• Verified date: September 2017
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute complicated type B aortic dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2017
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Presence of acute complicated type B aortic dissection:

• Dissection is acute Time from symptom onset to dissection diagnosis =14 days

• Dissection is complicated

Subject must present with at least one of the following:

• Rupture in the setting of an aortic dissection defined as hemorrhage outside of the aortic boundaries -which is noted by CT scan (hemorrhage must be differentiated from reactive effusions by the investigator, or if equivocal, having elevated Hounsefield units as determined by the radiologist).

• Clinical evidence of malperfusion, in the setting of an aortic dissection, defined as:

• Clinical or radiographic evidence of visceral hypoperfusion.

• Clinical or radiographic evidence of renal hypoperfusion.

• Clinical or radiographic evidence of lower extremity hypoperfusion.

• Clinical or radiographic evidence of spinal cord hypoperfusion.

• Dissection is type B Entire dissection is distal to the left subclavian artery

• Primary Treatment Indication is Class 1 Aortic Dissection 46 Classical aortic dissection with intimal flap between true and false lumen with double barrel flow in thoracic aorta

• Subjects with multiple entry tears are allowed to be enrolled in the study

2. Age 18 to 80 years

3. Primary treatment is endovascular treatment with the CTAG device. Adjunctive treatments may include left subclavian artery revascularization, percutaneous fenestration, aortic stenting, peripheral vessel stenting, surgical fenestration, and/or peripheral artery bypass

4. Proximal landing zone characteristics include:

• Proximal extent of intended proximal landing zone cannot be dissected

• Length = 2.0 cm proximal to the primary entry tear

• Trans-aortic diameter at proximal extent of intended landing zone between 16-42 mm (diameter assessed by flow lumen and thrombus, if present; calcium excluded)

• Cannot be aneurysmal, heavily calcified, or have excessive intraluminal thrombus

• Must be native aorta

• May include left subclavian artery, if necessary

5. Subject is capable of complying with protocol requirements, including follow-up

6. Informed Consent Form is signed by subject or legal representative

Exclusion Criteria:

1. Primary treatment indication is Class 2-5 aortic dissection (intramural hematoma, limited dissection, penetrating atherosclerotic ulcer, iatrogenic dissection, traumatic dissection) 46

2. Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair (dissection extension into the abdominal aorta is acceptable)

3. Prior repair of DTA

4. Infected aorta

5. Subject has a systemic infection and may be at increased risk of endovascular graft infection

6. Persistent refractory shock (systolic blood pressure <90 mm Hg)

7. Bowel necrosis (Bowel necrosis will be characterized by direct observation with surgical exploration, or elevated serum lactate level and CT findings of portal venous gas, free intra-abdominal gas, pneumatosis intramural gas, and poor mucosal enhancement of thickened bowel wall)

8. Renal failure , defined as baseline creatinine = 2.5 mg/dl

9. ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation)

10. Pregnant female

11. Major surgery within 30 days of treatment (other than left subclavian artery bypass or transposition)

12. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome

13. Treatment in another drug or medical device study within 1 year of study enrollment

14. History of stimulant abuse, e.g., cocaine or amphetamine, within 1 year of treatment

15. Tortuous or stenotic iliac and/or femoral arteries and the inability to use a conduit for vascular access

16. Planned coverage of left carotid or celiac arteries with the CTAG device

17. The planned endovascular procedure involves alterations to the CTAG device

18. Subject has known sensitivities or allergies to the device materials

Related Conditions & MeSH terms

• Type B Aortic Dissection

Intervention

Device:
• GORE TAG® Thoracic Endoprosthesis
Endoprosthetic Implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality Incidence Through 30 Days Post-treatment		30 Days Post-Treatment
Primary	Exclusion of Primary Entry Tear	Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery	1 month
Secondary	False Lumen Thrombosis	Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.	Last available follow-up through 5 years
Secondary	Aortic Rupture	Number of participants with thoracic aortic rupture	Last available follow-up through 5 years
Secondary	Additional Dissection Based Intervention Rate	Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.	Last available follow-up through 5 years