Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Launched by BAPTIST HEALTH SOUTH FLORIDA · Jan 31, 2012

Keywords

ClinConnect Summary

The clinical trial titled "Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms" is studying two types of specialized devices designed to treat aortic aneurysms, which are bulges in the aorta that can be dangerous if they grow too large. The first part of the study focuses on the Cook Zenith t-Branch endovascular stent-graft system, while the second part examines the Terumo Arch Branch Endograft for patients with specific aortic issues that can't be treated with standard options. Both studies aim to gather important information about these devices to improve treatment for patients with thoracoabdominal and aortic arch aneurysms.

To be eligible for this trial, participants should be between 65 and 74 years old and have certain types of aortic aneurysms that meet specific size or growth criteria. For example, they might have an aneurysm that is larger than 55mm in men or 50mm in women, or they might have a history of rapid growth in the aneurysm. Participants will undergo regular check-ups and will need to provide informed consent before joining the trial. It's important to note that individuals with certain medical conditions or those who are pregnant or breastfeeding won't be able to participate. This study is currently recruiting, and it offers a chance for patients to receive innovative treatments while contributing to medical research.

Gender

ALL

Eligibility criteria

• 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.