Vascular: Clinical Studies Open For Enrollment
-
Eligibility
- Male or female ≥ 20 years old
- Subject and the treating physician agree that the subject will return for all required follow-up visits
- Subject has an aneurysm diameter of:
- o ≥ 5 cm (if woman)
- o ≥ 5.5 cm (if man)
- Exclusion: for matched healthy controls; Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
- Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05378347
Principal Investigators
Igor Laskowski, MD – Westchester Medical Center
Michael Schwartz, MD – Good Samaritan Hospital
Contact for Study Screening
-
Eligibility
- Female ≥ 18 years at Screening
- Female Patients having ESRD, receiving successful hemodialysis via dialysis catheter currently, and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an HAV for HD access
- Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 12 months after SA implantation
- Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight, curved, or looped HAV in either the forearm or upper arm
- Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3
- Patient, or their legal representative, can communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits
- Patient must have a life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤8
- Exclusion criteria:
- Male sex at birth
- Planned AVF creation by means other than suture or vascular anastomotic clips (e.g., endovascular surgery or other anastomotic creation devices). Venous outflow from study access cannot be located more distally than the venous outflow of any previous failed access in that extremity
- Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy
- Pregnancy, or women intending to become pregnant during the course of the trial
- Treatment with any investigational drug or device within 60 days or 5 half-lives after taking the last dose (whichever is longer) prior to study entry (Day 1) or ongoing participation in a clinical trial of an investigational product; patients participating in clinical registries may be eligible
- Documented hyper-coagulable state, as defined as either:
- A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) – OR
- A clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g., DVT, PE, etc.) within the previous 5 years
- Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand’s disease, etc.)
- Previous exposure to HAV
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05908084
Principal Investigator
Romeo Mateo, MD
Contact for Study Screening
-
Eligibility
- Male or Female, Age > 21 years or minimum age (is allowed the inclusion of subjects > 21 years OR adulthood minimum age (depending on the US state regulations)
- Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
- Rutherford class 5 to 6 in the target limb with documented WIFI score.
- Intraoperative Inclusion Criteria:
- Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (>50% stenosis) can be included if lesion had been treated successfully (<30% residual stenosis) before or during the index procedure.
- Target vessel has angiographically documented unimpaired (<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery).
- Exclusion criteria:
- Comorbid conditions limiting life expectancy ≤ 1 year.
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet.
- Subject is lactating, pregnant or planning to become pregnant during the course of the study.
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:
- Osteomyelitis including and/or proximal to the metatarsal head.
- Gangrene involving the plantar skin of the forefoot, midfoot, or heel.
- Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel.
- Full thickness heel ulcer with/without calcaneal involvement.
- Any wound with calcaneal bone involvement.
- Wounds that are deemed to be neuropathic or non-ischemic in nature.
- Wounds that would require flap coverage or complex wound management for large soft tissue defect.
- Full thickness wounds on the dorsum of the foot with exposed tendon or bone.
- Prior bypass surgery of target vessel.
- Planned amputation of the target limb (major).
- Previously implanted stent in the target lesion.
- Intraoperative Exclusion Criteria:
- Failure to successfully cross the target lesion with a guide wire.
- Target vessel has lesions extending beyond the ankle joint.
- Failure to obtain <30% residual stenosis prior to randomization.
- Lesions requiring retrograde access. Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.
- Use of DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons).
- For Inflow lesions and non-target lesions all the approved devices are allowed.
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT06182397
Principal Investigator
Romeo Mateo, MD
Contact for Study Screening
-
Eligibility
- Male or female, 18 Years and older
- Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
- An Informed Consent Form signed by subject or legal representative.
- Exclusion criteria:
- Any contraindications for the TAMBE Device according to the IFU.
- Planned parallel grafting with the TAMBE Aortic Component.
- Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT06578741
Principal Investigator
Igor Laskowski, MD
Contact for Study Screening