Is NCT04471909 recruiting in Stanford, CA?

Yes, NCT04471909 is currently recruiting participants at its Stanford, CA location. This aortic dissection clinical trial is actively enrolling qualified participants.

How do I join the aortic dissection clinical trial in Stanford?

To join this clinical trial in Stanford, 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 Stanford 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.

Aortic Dissection Clinical Trial in Stanford, CA

About This Aortic Dissection Study in Stanford

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Sponsor: Endospan Ltd.

Who Can Participate

Inclusion Criteria

Male and female age ≥ 18.

Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length

Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter

Distal/descending native landing zone of appropriate length

Distal/descending native landing zone of appropriate diameter

Brachiocephalic trunk native landing zone of appropriate length

Brachiocephalic trunk native landing zone of appropriate diameter

Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular

Appropriate aortic arch perpendicular diameter

Chronic dissection with at least one of the following conditions:

An aortic aneurysm with a maximum diameter ≥ 55 mm

Rapidly expanding false lumen (growth of \> 0.5 cm/6 months)

Compressed true lumen associated with end organ malperfusion

Symptomatic

Aneurysm with at least one of the following conditions:

Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm

Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending

Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm

Symptomatic aneurysm of the aortic arch

Aortic diameter growth rate \> 5mm per 6 months

Postoperative pseudoaneurysm expanding from anastomotic suture lines

Penetrating aortic ulcer with at least one of the following:

Symptomatic

Ulcer demonstrates expansion

Intramural hematoma with at least one of the following:

Symptomatic (persistent pain)

Transverse or longitudinal expansion on serial imaging

In the event of a lesion in the ascending aortic, the proximal/ascending native or previously implanted surgical graft the landing zone must be appropriate

Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.

Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA/MRA.

Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.

Subject is considered an appropriate candidate for an elective surgery.

Subject is considered to be at high risk for open repair, as determined by the investigator.

Access vessels, iliac/femoral \& brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories.

Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol.

Exclusion Criteria

Acute dissection

Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization)

Required emergent treatment, e.g., trauma, rupture

Acute vascular injury of the aorta due to trauma

Aortic rupture or unstable aneurysm

Received a previous stent or stent graft in the treated area (including planned landing area)

Required surgical or endovascular treatment of an infra-renal aneurysm at time of implantation

Planned major surgical or interventional procedure at time of screening, to be performed after the NEXUS™ implantation.

Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation, exclusive of planned procedures that are needed for the safe and effective placement of the stent graft (e.g. supra-aortic bypass).

Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 90 days prior to the planned implantation

Subjects with severe aortic valvular insufficiency as determined by echocardiography

Mechanical valve that preclude safe delivery of NEXUS™

Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)

Subject has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture

Life expectancy of less than 2 years

Unsuitable vascular anatomy

Subject who have a previously implanted surgical wrap of the ascending aorta

Any medical condition that, according to the investigator's decision, might expose the subject to increased risk by the investigational device or procedure.

An aneurysm that is mycotic, inflammatory or suspected to be infected.

Subject with hostile groins/axilla (scarring, obesity, or previous failed puncture) unless conduit are used.

Subjects with severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk

Subject is suffering from unstable angina or NYHA classification III and IV.

Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.

Subject with a contraindication to undergo angiography

Subject with known sensitivities or allergies to the device materials (including Nitinol \[NiTi\], polyester fabric \[PET\], tantalum \[TA\])

Clinical conditions that severely inhibit x-ray visualization of the Aorta.

Subject has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator

Acute renal failure; chronic renal failure (excluding dialysis); Creatinine \> 2.00 mg/dl

Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.

Active participation in another clinical study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints in this study, or subject is planning to participate in such study prior to the completion of this 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 Stanford?

Yes, this clinical trial (NCT04471909) has an active research site in Stanford, CA 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 Dissection Treatment Options in Stanford, CA

If you're searching for aortic dissection treatment options in Stanford, CA, this clinical trial (NCT04471909) 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 Stanford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aortic dissection 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 dissection clinical trials near you to find additional studies recruiting in your area.

Aortic Dissection Clinical Trial in Stanford, CA

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