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

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00908388
• Collaborator: (none)
• Enrollment: 50
• Locations: 37
• Arm: 1
• Duration (Months): 88.9
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type B Aortic Dissection	Device: GORE TAG® Thoracic Endoprosthesis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GORE Conformable TAG® Device Surgical Implant	Device: GORE TAG® Thoracic Endoprosthesis; Endoprosthetic Implant

Outcome Measures

Primary Outcome Measures

1. All-cause Mortality Incidence Through 30 Days Post-treatment [30 Days Post-Treatment]

2. Exclusion of Primary Entry Tear [1 month]

   Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery

Secondary Outcome Measures

1. False Lumen Thrombosis [Last available follow-up through 5 years]

   Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.

2. Aortic Rupture [Last available follow-up through 5 years]

   Number of participants with thoracic aortic rupture

3. Additional Dissection Based Intervention Rate [Last available follow-up through 5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Age 18 to 80 years

2. 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

3. 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

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

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35294
2		Los Angeles	California	United States	90095
3		San Francisco	California	United States	94143
4		Stanford	California	United States	4305
5		Torrance	California	United States	90509
6		Gainesville	Florida	United States	32610
7		Saint Petersburg	Florida	United States	33709
8		Tampa	Florida	United States	33606
9		Atlanta	Georgia	United States	30322
10		Chicago	Illinois	United States	60611
11		Peoria	Illinois	United States	61614
12		Indianapolis	Indiana	United States	46202
13		Kansas City	Kansas	United States	66160
14		Baltimore	Maryland	United States	21287
15		Boston	Massachusetts	United States	02114
16		Boston	Massachusetts	United States	02215
17		Ann Arbor	Michigan	United States	48109
18		Grand Rapids	Michigan	United States	49546
19		Minneapolis	Minnesota	United States	55407
20		Minneapolis	Minnesota	United States	55455
21		Plymouth	Minnesota	United States	55441
22		Saint Louis	Missouri	United States	63110
23		Saint Louis	Missouri	United States	63141
24		Lebanon	New Hampshire	United States	03756
25		Albany	New York	United States	12208
26		New York	New York	United States	10032
27		Chapel Hill	North Carolina	United States	27599
28		Charlotte	North Carolina	United States	28204
29		Durham	North Carolina	United States	27710
30		Cleveland	Ohio	United States	44195
31		Philadelphia	Pennsylvania	United States	19104
32		Pittsburgh	Pennsylvania	United States	15213
33		Memphis	Tennessee	United States	38120
34		Houston	Texas	United States	77030
35		Temple	Texas	United States	76508
36		Charlottesville	Virginia	United States	22908
37		Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Richard Cambria, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT00908388
• Other Study ID Numbers: TAG 08-01
• First Posted: May 25, 2009
• Last Update Posted: Oct 27, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by W.L.Gore & Associates: Acute, Complicated Type B Dissection
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

Participant Flow

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
Period Title: Overall Study
STARTED	50
COMPLETED	40
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (11.6)
Sex: Female, Male (Count of Participants)
Female	13 26%
Male	37 74%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	All-cause Mortality Incidence Through 30 Days Post-treatment
Time Frame	30 Days Post-Treatment

Outcome Measure Data

Analysis Population Description

All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
Measure Participants	50
Number [participants]	5 10%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GORE Conformable TAG® Device Surgical Implant
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.006
	Comments	(1-Posterior probability of meeting performance goal given the data)
	Method	Bayesian adaptive
	Comments

2. Secondary Outcome

Title	False Lumen Thrombosis
Description	Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.
Time Frame	Last available follow-up through 5 years

Outcome Measure Data

Analysis Population Description

Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
Measure Participants	45
Complete Thrombosis	38 76%
Partial Thrombosis	6 12%
Unknown	1 2%

3. Secondary Outcome

Title	Aortic Rupture
Description	Number of participants with thoracic aortic rupture
Time Frame	Last available follow-up through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
Measure Participants	50
Number [participants]	2 4%

4. Secondary Outcome

Title	Additional Dissection Based Intervention Rate
Description	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.
Time Frame	Last available follow-up through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
Measure Participants	50
Number [participants]	9 18%

5. Primary Outcome

Title	Exclusion of Primary Entry Tear
Description	Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description	Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
Measure Participants	40
Number [participants]	39 78%

Adverse Events

Time Frame	5 years
Arm/Group Title	GORE Conformable TAG® Device Surgical Implant
Arm/Group Description
All Cause Mortality
	GORE Conformable TAG® Device Surgical Implant
	Affected / at Risk (%)	# Events
Total	13/50 (26%)
Serious Adverse Events
	GORE Conformable TAG® Device Surgical Implant
	Affected / at Risk (%)	# Events
Total	38/50 (76%)
Blood and lymphatic system disorders
Anaemia	3/50 (6%)
Disseminated intravascular coagulation	1/50 (2%)
Febrile neutropenia	1/50 (2%)
Leukocytosis	1/50 (2%)
Pancytopenia	1/50 (2%)
Cardiac disorders
Acute myocardial infarction	3/50 (6%)
Angina pectoris	6/50 (12%)
Atrial fibrillation	2/50 (4%)
Cardiac arrest	2/50 (4%)
Cardiac failure	1/50 (2%)
Cardiac failure acute	1/50 (2%)
Cardiac failure congestive	3/50 (6%)
Cardio-respiratory arrest	2/50 (4%)
Cardiogenic shock	1/50 (2%)
Gastrointestinal disorders
Abdominal distension	1/50 (2%)
Abdominal hernia	1/50 (2%)
Abdominal pain	3/50 (6%)
Constipation	1/50 (2%)
Functional gastrointestinal disorder	1/50 (2%)
Gastrointestinal haemorrhage	1/50 (2%)
Gastrointestinal necrosis	2/50 (4%)
Haematemesis	1/50 (2%)
Ileus	2/50 (4%)
Lower gastrointestinal haemorrhage	1/50 (2%)
Nausea	1/50 (2%)
Pancreatitis	1/50 (2%)
Peptic ulcer	1/50 (2%)
Small intestinal obstruction	2/50 (4%)
Upper gastrointestinal haemorrhage	1/50 (2%)
Vomiting	2/50 (4%)
General disorders
Complication of device removal	1/50 (2%)
Multiple organ dysfunction syndrome	1/50 (2%)
Non-cardiac chest pain	1/50 (2%)
Pyrexia	4/50 (8%)
Stent-graft endoleak	6/50 (12%)
Hepatobiliary disorders
Ischaemic hepatitis	1/50 (2%)
Infections and infestations
Abdominal wall abscess	1/50 (2%)
Arthritis infective	1/50 (2%)
Bacteraemia	1/50 (2%)
Gastroenteritis	1/50 (2%)
Groin infection	1/50 (2%)
Infection	1/50 (2%)
Klebsiella infection	1/50 (2%)
Pneumonia	1/50 (2%)
Pneumonia pseudomonal	1/50 (2%)
Sepsis	2/50 (4%)
Urinary tract infection	3/50 (6%)
Injury, poisoning and procedural complications
Incision site oedema	1/50 (2%)
Incision site pain	1/50 (2%)
Lumbar vertebral fracture	1/50 (2%)
Postoperative ileus	2/50 (4%)
Vascular pseudoaneurysm	1/50 (2%)
Investigations
Troponin increased	1/50 (2%)
White blood cell count increased	2/50 (4%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/50 (2%)
Gout	1/50 (2%)
Hypocalcaemia	1/50 (2%)
Lactic acidosis	1/50 (2%)
Metabolic acidosis	1/50 (2%)
Obesity	1/50 (2%)
Musculoskeletal and connective tissue disorders
Back pain	2/50 (4%)
Compartment syndrome	1/50 (2%)
Haemarthrosis	1/50 (2%)
Lumbar spinal stenosis	1/50 (2%)
Muscular weakness	1/50 (2%)
Osteoarthritis	1/50 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic	1/50 (2%)
Renal cell carcinoma	1/50 (2%)
Nervous system disorders
Alcoholic seizure	1/50 (2%)
Basal ganglia infarction	1/50 (2%)
Brain injury	1/50 (2%)
Brain oedema	1/50 (2%)
Carotid artery dissection	1/50 (2%)
Carotid artery occlusion	1/50 (2%)
Cerebral ischaemia	1/50 (2%)
Cerebrovascular accident	4/50 (8%)
Encephalopathy	1/50 (2%)
Ischaemic stroke	1/50 (2%)
Monoplegia	1/50 (2%)
Paraesthesia	1/50 (2%)
Paraparesis	1/50 (2%)
Seizure	1/50 (2%)
Spinal cord infarction	1/50 (2%)
Spinal cord ischaemia	2/50 (4%)
Syncope	1/50 (2%)
Unresponsive to stimuli	1/50 (2%)
Psychiatric disorders
Delirium	1/50 (2%)
Delirium tremens	1/50 (2%)
Depression	1/50 (2%)
Mental status changes	1/50 (2%)
Suicide attempt	1/50 (2%)
Renal and urinary disorders
Acute kidney injury	5/50 (10%)
Anuria	1/50 (2%)
Chronic kidney disease	1/50 (2%)
Renal artery stenosis	1/50 (2%)
Renal atrophy	1/50 (2%)
Renal failure	1/50 (2%)
Renal impairment	1/50 (2%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	2/50 (4%)
Acute respiratory failure	2/50 (4%)
Chronic obstructive pulmonary disease	3/50 (6%)
Cystic lung disease	1/50 (2%)
Dyspnoea	1/50 (2%)
Haemothorax	1/50 (2%)
Hypoxia	4/50 (8%)
Pleural effusion	3/50 (6%)
Pneumonitis	2/50 (4%)
Pneumothorax	1/50 (2%)
Pulmonary embolism	1/50 (2%)
Pulmonary hypertension	1/50 (2%)
Pulmonary oedema	1/50 (2%)
Respiratory failure	8/50 (16%)
Vascular disorders
Accelerated hypertension	1/50 (2%)
Aortic aneurysm	2/50 (4%)
Aortic aneurysm rupture	1/50 (2%)
Aortic dissection	5/50 (10%)
Aortic dissection rupture	1/50 (2%)
Aortic rupture	1/50 (2%)
Deep vein thrombosis	1/50 (2%)
False lumen dilatation of aortic dissection	1/50 (2%)
Haemorrhage	1/50 (2%)
Hypertension	4/50 (8%)
Hypotension	2/50 (4%)
Labile blood pressure	1/50 (2%)
Orthostatic hypotension	1/50 (2%)
Peripheral artery stenosis	1/50 (2%)
Other (Not Including Serious) Adverse Events
	GORE Conformable TAG® Device Surgical Implant
	Affected / at Risk (%)	# Events
Total	42/50 (84%)
Blood and lymphatic system disorders
Anaemia	10/50 (20%)
Leukocytosis	4/50 (8%)
Thrombocytopenia	5/50 (10%)
Cardiac disorders
Angina pectoris	5/50 (10%)
Atrial fibrillation	6/50 (12%)
Bradycardia	3/50 (6%)
Cardiac failure congestive	3/50 (6%)
Pericardial effusion	3/50 (6%)
Gastrointestinal disorders
Abdominal pain	7/50 (14%)
Abdominal pain upper	3/50 (6%)
Ascites	3/50 (6%)
Constipation	4/50 (8%)
Diarrhoea	5/50 (10%)
Dysphagia	3/50 (6%)
Nausea	9/50 (18%)
Vomiting	3/50 (6%)
General disorders
Asthenia	3/50 (6%)
Non-cardiac chest pain	3/50 (6%)
Oedema peripheral	8/50 (16%)
Peripheral swelling	3/50 (6%)
Pyrexia	8/50 (16%)
Stent-graft endoleak	6/50 (12%)
Infections and infestations
Cellulitis	3/50 (6%)
Urinary tract infection	8/50 (16%)
Injury, poisoning and procedural complications
Device deployment issue	3/50 (6%)
Investigations
Blood creatinine increased	4/50 (8%)
Metabolism and nutrition disorders
Hyperglycaemia	3/50 (6%)
Hypernatraemia	3/50 (6%)
Hypokalaemia	4/50 (8%)
Hyponatraemia	4/50 (8%)
Musculoskeletal and connective tissue disorders
Back pain	8/50 (16%)
Muscular weakness	3/50 (6%)
Pain in extremity	7/50 (14%)
Nervous system disorders
Headache	5/50 (10%)
Hypoaesthesia	3/50 (6%)
Paraesthesia	5/50 (10%)
Psychiatric disorders
Depression	3/50 (6%)
Mental status changes	3/50 (6%)
Renal and urinary disorders
Renal failure	3/50 (6%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	13/50 (26%)
Pleural effusion	23/50 (46%)
Pulmonary oedema	4/50 (8%)
Vascular disorders
Haematoma	3/50 (6%)
Hypertension	4/50 (8%)
Hypotension	7/50 (14%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.