Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Thoracoabdominal Aortic Aneurysm Clinical Trial

Official title:

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524211
• Other study ID #: IDE G110081
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2012
• Est. completion date: January 2032

Study information

• Verified date: October 2023
• Source: Baptist Health South Florida
• Contact: Lisamarie Kernicky, RN;BSN;CCRC
• Phone: 561-955-5239
• Email: lkernicky[@]brrh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.

Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.

Description:

Study Update as of 5/31/2024; 179 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing. Arch Branch Subject Cohort enrollment is open.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: January 2032
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Zenith t-Branch Eligibility Criteria:

Inclusion Criteria

The patient must have one of the following:

1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):=55mm in diameter in a male or =50mm in diameter in a female, or

2. Thoracoabdominal aortic aneurysm with a history of growth =0.5 cm per year, or

3. Penetrating ulcers: =20mm in depth or

4. Chronic type B aortic dissections: =50mm total aortic diameter or

5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Additional criteria for LP material

• Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator

Exclusion Criteria

General Criteria

1. Life-expectancy less than 12 months

2. Refusal to receive blood products

3. Age <18 years

4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months

5. Unwilling to comply with the follow-up schedule

6. Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized

Medical Criteria

1. Uncontrolled systemic infection

2. Untreatable malignancy

3. Uncontrollable anaphylaxis to iodinated contrast

4. Known allergy(ies) to device materials

Anatomic Criteria

1. Any pathology of mycotic origin

2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)

3. Inability to insert the Zenith® t-Branch device through iliofemoral approach

4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm

5. Proximal landing zone length <25mm to allow secure fixation and seal

6. Proximal landing zone diameter of <24mm or >42mm

7. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries

8. Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries

Terumo Arch Branch Eligibility Criteria

Inclusion Criteria

The subject must have one of the following:

1. Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta =55 mm in diameter or > 50 mm with a history of growth =5 mm in the last 6 months, or

2. Penetrating ulcers: =20 mm in depth, or

3. Chronic aortic dissections: =50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.

1. Age >85 years old.

2. Prior median sternotomy (for any reason).

3. Prior open or endovascular thoracic aortic repair.

4. Severe aortic calcification.

5. Severe occlusive disease of one or more arch vessels.

6. Moderate-severe COPD (FEV1 <80% predicted).

7. Severe CKD (Stage 3 or greater, eGFR <60 mL/min).

8. LV dysfunction.

9. Chronic steroid or immunosuppressive use.

10. History of increased risk of bleeding.

11. Neurocognitive deficits that may significantly impact postoperative rehabilitation.

12. Musculoskeletal conditions that may significantly impact postoperative rehabilitation.

Exclusion Criteria

General Criteria

1. Life expectancy <1 year.

2. Refusal to receive blood products.

3. Age <18 years.

4. Pregnant, breastfeeding, or planning to become pregnant within 60 months.

5. Unwilling to comply with the follow-up schedule.

6. Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized.

7. Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution.

Medical Criteria

1. Pending cardiac surgery.

2. Untreatable severe, symptomatic coronary or valvular disease.

3. Prior mechanical aortic valve replacement (not bioprosthetic).

4. History of TAVR (Transcatheter Aortic Valve Replacement)

5. Severe, calcific aortic valvular stenosis.

6. Uncontrolled systemic infection.

7. Untreatable malignancy with <1 year expected survival.

8. Uncontrollable anaphylaxis to iodinated contrast.

9. Known allergy(ies) to device materials. (i.e. polyester, nitinol).

Anatomic Criteria

1. Any pathology of mycotic origin.

2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).

3. Acute (<2 weeks) aortic dissection.

4. Type A dissection.

5. Symptomatic or ruptured pathology.

6. Anatomy suitable for repair using commercially-available endograft.

7. Inability to insert the Arch Branch endograft through an iliofemoral approach.

8. Untreated, known extracranial carotid stenosis >80%.

9. Ascending aortic angulation with radius of curvature <15mm in the intended landing zone.

10. Proximal aortic landing zone length <25 mm.

11. Proximal aortic landing zone diameter of >43mm or <28 mm.

12. Distal aortic landing zone diameter <20 mm.

13. Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk <70mm.

14. Target arch vessels:

15. Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter >24 mm or <6 mm, length <15 mm. ii. Common carotid artery: Diameter <6 mm, length <25mm. iii. Subclavian artery: Diameter <6 mm, length <25mm.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Aortic Arch Aneurysm
• Thoracoabdominal Aortic Aneurysm

Intervention

Device:
• Zenith® t-Branch
The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.
• Terumo Arch Branch
The Arch Branch endograft is a custom-made endograft based on the Relay thoracic stent graft platform. The device is intended to land proximally in the ascending aorta just distal to the sinotubular junction, and distally either in the native thoracic aorta for focal arch pathologies, or more extensive pathologies either extended with another commercially available thoracic endograft or mated to a pre-existing thoracic endograft, which would serve as a distal landing zone. It is constructed of polyester graft material (same as those used for the Terumo Relay Plus or Pro) sewn to self-expanding nitinol stents with suture. The graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the stents provide the necessary attachment and seal of the graft to the aortic wall.

Locations

Country	Name	City	State
United States	Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)	Boca Raton	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Baptist Health South Florida	Bolton Medical, William Cook Australia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Mortality & Stroke	The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment.	30 days post implant of the branch endografts
Secondary	Rates of Neurologic Complications/Late Branch Vessel Patency	The secondary aims of this study are to determine the rates of neurologic complications and late branch/target vessel patency, type I and III endoleaks and secondary interventions after branch endograft treatment. In those subjects enrolled in the t-Branch cohort we will evaluate the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms.	Day 0-Day 30 (Early) Day 31-1825 (Late)