Is NCT04746677 recruiting in Boston, MA?

Yes, NCT04746677 is currently recruiting participants at its Boston, MA location. This abdominal aortic aneurysm clinical trial is actively enrolling qualified participants.

How do I join the abdominal aortic aneurysm clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Abdominal Aortic Aneurysm Clinical Trial in Boston, MA

About This Abdominal Aortic Aneurysm Study in Boston

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

Sponsor: Beth Israel Deaconess Medical Center

Who Can Participate

Inclusion Criteria

General inclusion criteria (applicable to all 3 study arms):

Aortic pathology that fits one of the study arms (see below for detailed description)

Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device

Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing

Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity

Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit

Non-aneurysmal aortic segment proximal to the aortic pathology with a:

Minimum neck length of 20 mm

Diameter between 20 - 42 mm

Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:

Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm

Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm

Age ≥21 years old

Life expectancy: ≥2 years Arm1:

Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm

Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus

Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease above the diaphragmatic hiatus

Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture

Symptomatic complex aortic aneurysm

Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus

Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus Arm2:

Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months

Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair with aneurysmal disease extending above the diaphragmatic hiatus

Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair

Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, with aneurysmal disease above the diaphragmatic hiatus

Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture

Symptomatic type I, II, or III thoracoabdominal aortic aneurysm

Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus

Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus Arm 3:

Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy

Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)

Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy Arm 4

Patient does not meet the inclusion/

Exclusion Criteria

of Arms 1 - 3

Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option

Estimated perioperative risk is lower than the estimated 1-year mortality without surgery EXCLUSION CRITERIA: General Exclusion Criteria

Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

Subject is unwilling to comply with the follow-up schedule

Inability or refusal to give informed consent by subject or legal representative

Subject is pregnant or breastfeeding

Subject has a ruptured aneurysm Arm 5 • Patient meets criteria for Arms 1-4 \- Patient is undergoing repair using the TREO bifurcated stent graft Indications for using TREO bifurcated stent graft:

Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR

-Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) \< 115 mm; OR

In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR

Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha/Alpha 2 endograft. Medical Exclusion Criteria

Known sensitivities or allergies to the materials of construction of the devices

Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed

Uncorrectable coagulopathy

Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment

Systemic or local infection that may increase the risk of endovascular graft infection

Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) Anatomic Exclusion Criteria

Inability to perform open or endovascular iliac conduit in patients with inadequate femoral/iliac access

Excessive thrombus or calcification within the neck of the aneurysm

Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size

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 Boston?

Yes, this clinical trial (NCT04746677) has an active research site in Boston, MA 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.

Abdominal Aortic Aneurysm Treatment Options in Boston, MA

If you're searching for abdominal aortic aneurysm treatment options in Boston, MA, this clinical trial (NCT04746677) 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 Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced abdominal aortic aneurysm 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 abdominal aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

Abdominal Aortic Aneurysm Clinical Trial in Boston, MA

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