Surgery: Clinical Studies Open For Enrollment
- Post-Market Registry in Europe and US for the Use of VascuCel
- A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure.
- Profiling of plasma before and after anticoagulant therapy in patients diagnosed with Venous Thromboembolism (VTE)
- Phase 1/2, Open label & double blind randomized placebo-controlled study to assess the feasibility of BGC101 (EnEPC) in the treatment of peripheral arterial disease (PAD) with critical limb ischemia (CLI)
- Medtronic EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)
- Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds
- Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers
- Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
- REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial
- Evaluation of the GORE Ascending Stent Graft (ASG device) in the Treatment of Lesions of the Ascending Aorta
- A Phase 3 Randomized Study to Compare the Efficacy and Safety of the Humacyte Human Acellular Vessel (HAV) with that of an Autogenous Arteriovenous Fistula (AVF) in Female Patients with End-Stage Renal Disease Requiring Hemodialysis
Post-Market Registry in Europe and US for the Use of VascuCel
Eligibility
- Male or female ≥18 years of age
- Patient is a candidate for treatment with VascuCel per approved device indications.
- Exclusion: No study specific exclusion criteria; patients treated per standard clinical practice
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT04906824
Principal Investigator
Romeo Mateo, MD
Contact for Study Screening
Anuritha.Tirumani@wmchealth.org
A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure.
Eligibility
- Participants at least 18 years of age at enrollment.
- Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
- In the opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy.
- For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of >0.5 international unit per milliliter (IU/mL) at screening.
- Women of childbearing potential should have a negative pregnancy test documented prior to enrollment
- Participant or legally authorized representative willing to sign e-consent/written informed consent form.
Enrollment Status: Pending site activation
Study Information
ClinicalTrials.gov | NCT05156983
Principal Investigator
Kartik Prabhakaran, MD
Contact for Study Screening
Falyn.Katzman@wmchealth.org
Christopher.Hall2@wmchealth.org
Profiling of plasma before and after anticoagulant therapy in patients diagnosed with Venous Thromboembolism (VTE)
Eligibility
- Male or female 18 - 80 years of age
- Able and willing to sign an informed consent
- Cancer induced Thrombosis
- Diagnosis of VTE (before and after anticoagulant therapy)
- Exclusion: Unwilling to sign informed consent
Enrollment Status: Open to enrollment
Principal Investigator
Matthew Bronstein, MD
Contact for Study Screening
Falyn.Katzman@wmchealth.org
Eligibility
- Male or female at least 18 years of age
- Have the time and ability to complete the study and comply with instructions.
- Non-pregnant and non-lactating female patients.
- Have the clinical indications diagnostic of CLI based on Rutherford category 4-5
- Exclusion: for matched healthy controls; Severe and uncorrected aorto-iliac and/or common femoral artery disease, i.e. absence of femoral pulse or monophasic common femoral artery doppler waveform, Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the feasibility of the study medication, Treatment with any investigational product within the last six months or enrollment in any active study involving the use of investigational devices or drugs and Presence of any other condition or circumstance that, in the judgment of the investigator, might negatively impact the outcomes of the treatment under investigation.
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT02805023
Principal Investigator
Igor Laskowski, MD
Contact for Study Screening
Anuritha.Tirumani@wmchealth.org
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
Anuritha.Tirumani@wmchealth.org
Eligibility
- Hospitalized patients, patients admitted for observation, and outpatients who are receiving acute burn care.
- Men and non-pregnant/non-lactating women 18 to 65 years old.
- Diagnosis of partial thickness burn wounds <20% TBSA.
- Burn injury should be no more than 48 hours old when being consented for study enrollment.
- Burn with no previous intervention except for initial first aid/triage.
- Willing and able to comply with protocol-mandated scheduled clinical evaluations/study visits.
- Exclusion criteria:
- Known allergy or sensitivity to TPD product or its components.
- Women who are pregnant, breast feeding, or planning to become pregnant during the study period.
- Infected wounds (clinical diagnosis).
- Presence of any full thickness (third degree) burn(s).
- Electrical burns.
- Heavily draining burns.
- Concurrent clinical condition within the judgement of the clinician that would pose a health risk to patient, delay wound healing or otherwise influence outcome of study.
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05424354
Principal Investigator
Joseph Turkowski, MD
Contact for Study Screening
Anuritha.Tirumani@wmchealth.org
Eligibility
- Men or non-pregnant/non-lactating women 18-89 years of age
- Diagnosed with diabetes mellitus with Hgb A1C <12%
- Diabetic foot ulcer present >30 days
- Diabetic Foot Ulcer (DFU) classification: Wagner Grade 1 or 2 ulcers
- Wound drainage is minimal or moderate
- No clinically active wound infection (clinical diagnosis)
- Exclusion criteria:
- Known allergy to TPD
- Highly exudative wounds
- Wounds with necrosis unable to undergo debridement
- Active gangrene
- Body Mass Index (BMI) >45 kg/m2
- Wounds impending surgical intervention (including revascularization or plastic surgery)
- Untreated osteomyelitis
- Soft tissue infection (based on clinical diagnosis)
- Active Charcot arthropathy
- Untreated HIV
- Impending organ transplant
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05046158
Principal Investigator
Igor Laskowski, MD
Contact for Study Screening
Anuritha.Tirumani@wmchealth.org
Eligibility
- 18 Years to 85 Years (Adult, Older Adult)
- Stage 2, 3, or 4 Pressure Injuries;
- Wound exudate is mild to moderate;
- No clinically active wound infection (clinical diagnosis);
- Able and willing to provide written (not proxy) informed consent;
- Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.
- Exclusion criteria:
- Known allergy or hypersensitivity to TPD or its components;
- Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
- Heavily exudative wounds;
- Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema >0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;
- Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months);
- Body Mass Index (BMI) >45 kg/m2;
- Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
- Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on the affected limb, if wound is located on the limb);
- Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
- Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;
- Wounds with necrosis unable to undergo prior definitive debridement;
- Fistulas;
- Active gangrene;
- Untreated HIV
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05496296
Principal Investigator
Helen Perakis, MD
Contact for Study Screening
Anuritha.Tirumani@wmchealth.org
Eligibility
- Female sex (RECHARGE: Women)
- Black race or Hispanic ethnicity (RECHARGE: Minorities)
- Patient is at least 18 years old
- Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
- Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires
- Exclusion criteria:
- ST-segment elevation MI within 3 days
- Cardiogenic shock
- Prior PCI within 1 year or any prior cardiac surgery
- Planned hybrid revascularization (PCI after CABG or CABG after PCI)
- Planned single vessel revascularization (other than isolated left main disease)
- Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years *NOTE: The one exception is that surgical or interventional left atrial appendage ligation or occlusion may be performed either during or subsequent to the index procedure if clinically indicated
- Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT06399705
Principal Investigator
Suguru Ohira, MD
Contact for Study Screening
Corazon.DeLaPena@wmchealth.org
Eligibility
- Male or female, 18 Years and older
- Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm
- Fusiform aneurysm (≥50mm or documented growth rate >0.5cm/year)
- Saccular aneurysm (no diameter criteria)
- Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysm
- Penetrating Aortic Ulcers (PAUs) (no diameter criteria)
- Pseudoaneurysms, following open surgical repair of a Type A dissection (>30 days post-surgery, no diameter criteria)
- Anatomic compatibility with ASG device based on Gore Imaging Sciences review
- Treatment must be limited to the ascending aorta
- Lesion location is ≥2cm distal to the most distal coronary artery ostia
- Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic Artery (BCA)
- Proximal and distal landing zones must be ≥2cm in length
- Landing zones cannot be heavily calcified, or heavily thrombosed
- Landing zone diameter between 27mm - 48mm
- For patients with prior replacement of the ascending aorta and/or aortic arch by an endovascular or surgical graft, there must be at least ≥2 cm overlap of ASG device and previously implanted graft.
- Exclusion criteria:
- De novo Type A dissection
- Requires immediate treatment
- Dissected great vessels requiring treatment
- Anticipated need for coronary or aortic valve intervention within one-year post treatment
- Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
- Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment
- Open chest surgical repair within 30 days prior to treatment
- Presence of Intramural Hematoma (IMH) in landing zones
- Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device
- Aortic insufficiency grade 3 or greater
Enrollment Status: Open to enrollment
Study Information
ClinicalTrials.gov | NCT05800743
Principal Investigator
Suguru Ohira, MD
Contact for Study Screening
Corazon.DeLaPena@wmchealth.org
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
Anuritha.Tirumani@wmchealth.org