Physician

Ellen Redstone, MD

Study Coordinator

Danielle Schneider
email: Danielle.Schneider@sluhn.org
phone: 484-658-4982

 

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To demonstrate safety and assess the clinical use and outcomes of the LUTONIXTM DCB for treatment of dysfunctional AV fistulae located in the arm in a heterogeneous patient population in real world clinical practice.

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1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
2. Subject is willing to provide informed consent, and is willing to co ply with the protocol-required follow up visits;
3. Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;
4. Subject has a target lesion that can be treated with available LUTONIXTM DCB according to the Instructions For Use (IFU);
5. Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein;
6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
   • a) No clinically significant dissection;
   • b) No extravasation requiring treatment;
   • c) Residual stenosis ≤30% by angiographic measurement;
   • d) Ability to completely efface the waist using the pre-dilation balloon.

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Physician

Ellen Redstone, MD

Study Coordinator

Danielle Schneider
email: Danielle.Schneider@sluhn.org
phone: 484-658-4982

 

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FlowTriever System versus Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism (PE).

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Subjects must meet each of the following criteria to be included in the study:

1. Age ≥18 years old

2. Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery

3. Including ALL of the following:
a. Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI
AND
b. Hemodynamically stable
AND
c. RV dysfunction on echocardiography or CT
AND
d. Any one or more of the following present at the time of diagnosis:
i. Elevated cardiac troponin levels
ii. History of heart failure
iii. History of chronic lung disease
iv. Heart rate ≥ 110 beats per minute
v. SBP <100mmHg
vi. Respiratory rate ≥ 30 breaths per minute
vii. O2 saturation <90%
viii. Syncope related to PE
ix. Elevated lactate

4. Intervention planned to begin within 72 hours of the later of either
a. Confirmed PE diagnosis
OR
b. If transferring from another hospital, arrival at the treating hospital

5. Symptom onset within 14 days of confirmed PE diagnosis

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