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New treatment option for Thoracoabdominal Aortic Aneurysm
Official title Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
ClinicalTrials.gov ID: NCT01524211
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Zenith t-Branch Eligibility Criteria: The patient must have one of the following:
- Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or...
- Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
- Penetrating ulcers: ≥20mm in depth or
- Chronic type B aortic dissections: ≥50mm total aortic diameter or
You likely can't join if
- General Criteria
- Life-expectancy less than 12 months
- Refusal to receive blood products
- Age \<18 years
- Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
See the full eligibility criteria
Who can join
- Zenith t-Branch Eligibility Criteria: The patient must have one of the following:
- 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
- Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
- Penetrating ulcers: ≥20mm in depth or
- Chronic type B aortic dissections: ≥50mm total aortic diameter or
- 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
What rules you out
- General Criteria
- Life-expectancy less than 12 months
- Refusal to receive blood products
- Age \<18 years
- Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized Medical Criteria
- Uncontrolled systemic infection
- Untreatable malignancy
- Uncontrollable anaphylaxis to iodinated contrast
- Known allergy(ies) to device materials Anatomic Criteria
- Any pathology of mycotic origin
- Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
- Inability to insert the Zenith® t-Branch device through iliofemoral approach
- Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
- Proximal landing zone length \<25mm to allow secure fixation and seal
- Proximal landing zone diameter of \ 42mm
- Distal landing zone length \<25mm in the abdominal aorta or \<20mm in the iliac arteries
- Distal landing zone diameter of \ 30mm in the abdominal aorta, or \ 28mm in the iliac arteries Terumo Arch Branch Eligibility Criteria Inclusion Criteria The subject must have one of the following:
- 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
- Penetrating ulcers: ≥20 mm in depth, or
- 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.
- Age \>85 years old.
- Prior median sternotomy (for any reason).
- Prior open or endovascular thoracic aortic repair.
- Severe aortic calcification.
- Severe occlusive disease of one or more arch vessels.
- Moderate-severe COPD (FEV1 \<80% predicted).
- Severe CKD (Stage 3 or greater, eGFR \<60 mL/min).
- LV dysfunction.
- Chronic steroid or immunosuppressive use.
- History of increased risk of bleeding.
- Neurocognitive deficits that may significantly impact postoperative rehabilitation.
- Musculoskeletal conditions that may significantly impact postoperative rehabilitation. Exclusion Criteria General Criteria
- Life expectancy \<1 year.
- Refusal to receive blood products.
- Age \<18 years.
- Pregnant, breastfeeding, or planning to become pregnant within 60 months.
- Unwilling to comply with the follow-up schedule.
- Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized.
- Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution. Medical Criteria
- Pending cardiac surgery.
- Untreatable severe, symptomatic coronary or valvular disease.
- Prior mechanical aortic valve replacement (not bioprosthetic).
- History of TAVR (Transcatheter Aortic Valve Replacement)
- Severe, calcific aortic valvular stenosis.
- Uncontrolled systemic infection.
- Untreatable malignancy with \<1 year expected survival.
- Uncontrollable anaphylaxis to iodinated contrast.
- Known allergy(ies) to device materials. (i.e. polyester, nitinol). Anatomic Criteria
- Any pathology of mycotic origin.
- Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).
- Acute (\<2 weeks) aortic dissection.
- Type A dissection.
- Symptomatic or ruptured pathology.
- Anatomy suitable for repair using commercially-available endograft.
- Inability to insert the Arch Branch endograft through an iliofemoral approach.
- Untreated, known extracranial carotid stenosis \>80%.
- Ascending aortic angulation with radius of curvature \<15mm in the intended landing zone.
- Proximal aortic landing zone length \<25 mm.
- Proximal aortic landing zone diameter of \>43mm or \<28 mm.
- Distal aortic landing zone diameter \<20 mm.
- Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk \<70mm.
- Target arch vessels:
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boca Raton, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boca Raton, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.