Philadelphia, PANCT02323581Now EnrollingIRB Ready

Aortic Aneurysm, Thoracoabdominal Clinical Trial in Philadelphia, PA

Access cutting-edge aortic aneurysm, thoracoabdominal treatment through this clinical trial at a research site in Philadelphia. Study-provided care at no cost to qualified participants.

Sponsored by Darren Schneider, M.D.

Quick Self-Assessment

See if you qualify for this Philadelphia location

Preparing your pre-screening questions…

Expert Care in Philadelphia

Access aortic aneurysm, thoracoabdominal specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aortic aneurysm, thoracoabdominal treatment provided free

Apply for This Philadelphia Location

Check if you qualify for this aortic aneurysm, thoracoabdominal clinical trial in Philadelphia, PA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Philadelphia

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Philadelphia site if eligible
  4. 4Begin participation

About This Aortic Aneurysm, Thoracoabdominal Study in Philadelphia

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Sponsor: Darren Schneider, M.D.

Who Can Participate

Inclusion Criteria

Presence of TAAA in:
Men with TAAA greater than or equal to 6 cm in diameter
Women with TAAA greater than or equal to 5 cm in diameter
Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
Life expectancy more than 2 years
Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
Proximal aortic landing zone:
≥ 20mm long
≤ 40mm and ≥ 20mm diameter in parallel aorta
free from circumferential thrombus
≤ 60 degrees angulation
Mesenteric/renal aortic diameter ≥ 20mm
Mesenteric arteries:
≥ 10mm long segment of healthy artery for branch attachment
Diameter ≥ 4mm and ≤ 12mm
Absence of aberrant or early branching, aneurysm or dissection
Renal arteries:
≥ 10mm long segment of healthy artery for branch attachment
Diameter ≥ 4mm and ≤ 8mm
Absence of aberrant or early branching, aneurysm or dissection
Iliac artery access:
≥ 6mm diameter, and absence of severe calcification and tortuosity
Or, planned creation of surgical conduit for TAAA device delivery
For patients with associated common iliac artery aneurysms (\>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):
≥ 10mm long segment of healthy internal iliac artery for branch attachment
Internal iliac diameter ≥ 5mm and ≤ 12mm
External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
Minimum common iliac artery luminal diameter ≥ 14mm
Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery
Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
Age ≥ 65 year
Cardiac disease:
CAD (history of MI or angina with positive stress test and not revascularizable)
LV Ejection fraction \< 40%
Symptomatic CHF (NYHC Class II, III, or IV)
Pulmonary disease:
Home oxygen therapy
FEV1 \< 1.2 l/s
Vital capacity \< 50% predicted
PaCO2 \> 45 mm Hg or \< 60 mm Hg
Renal disease:
ESRD on dialysis
Prior aortic surgery
Hostile abdomen
Portal hypertension (ascites or varices)
Coagulopathy AORTIC ARCH STUDY ARM Inclusion Criteria:
Presence of aortic arch aneurysm in:
Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or
Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or
Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation
Life expectancy more than 2 years
Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.
Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":
Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass
Proximal aortic landing zone:
Native aorta or surgical graft
≥ 20 mm long
≤ 42 mm and ≥ 20 mm diameter in parallel aorta
free from circumferential thrombus
Distal aortic landing zone:
Native aorta or surgical graft
≥ 20 mm long
≤ 42 mm and ≥ 20 mm diameter in parallel aorta
free from circumferential thrombus
≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery
Adequate supra-aortic trunk branch landing zone(s):
Innominate artery (if applicable):
Native vessel or surgical graft
Diameter: 8-22mm
Length of sealing zone ≥10mm
Acceptable tortuosity
Absence of dissection in landing zone
Left (or right) common carotid artery (if applicable):
Native vessel or surgical graft
Diameter 6-16mm
Length of sealing zone ≥10mm
Acceptable tortuosity
Absence of dissection in landing zone
Left (or right) subclavian artery (if applicable):
Native vessel or surgical graft
Diameter: 5-20mm
Length of sealing zone ≥10mm
Acceptable tortuosity
Absence of dissection in landing zone
Iliac artery access:
≥ 6mm diameter, and absence of severe calcification and tortuosity
Or, planned creation of surgical conduit for TAAA device delivery
Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):
Age \> 70 years-old
Prior ascending or aortic arch repair
Multiple (≥2) median sternotomies
Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
Chronic pulmonary disease with FEV1 \< 1500ml
Chronic kidney disease with eGFR ≤ 60 ml/kg/hr
Large aneurysm abutting the sternotomy
Severe deconditioning or immobility
Prior cervical irradiation
Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery) APPLIES TO BOTH STUDY ARMS

Exclusion Criteria

Rupture, with hypotension (systolic bp \< 90).
Pregnancy or breastfeeding.
Unwillingness or inability to comply with the follow up schedule.
Serious systemic or groin infection.
Uncorrectable coagulopathy.
Age \< 18 years.
Mycotic aneurysm.
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
Participation in another in another investigational device or drug study within 1 year of treatment.
Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)
Body habitus that would inhibit X-ray visualization of the aorta.
Acute aortic dissection
Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT02323581) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Aortic Aneurysm, Thoracoabdominal Treatment Options in Philadelphia, PA

If you're searching for aortic aneurysm, thoracoabdominal treatment options in Philadelphia, PA, this clinical trial (NCT02323581) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic aneurysm, thoracoabdominal specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all aortic aneurysm, thoracoabdominal clinical trials near you to find additional studies recruiting in your area.

More Heart Attack Trials in Philadelphia, PA

See all heart attack clinical trials recruiting in Philadelphia — not just this study.

Browse Heart Attack Trials in Philadelphia →

Browse More Trials by Condition

Heart Attack TrialsAortic Aneurysm TrialsRheumatoid Arthritis TrialsOveractive Bladder TrialsInterstitial Cystitis TrialsOsteoarthritis TrialsMyocardial Infarction TrialsAll Conditions →

Ready to Join in Philadelphia?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Philadelphia, PA