Clinical trials: Vascular Surgical Procedures
Spinal Anesthesia, Vascular Surgery
Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery
This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
- Trial name
- NCT03883763
- Testing
- bupivacaine S75:R25 plus 8% glucose, bupivacaine S50:R50 plus 8% glucose
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Surgical Wound
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.
Hypertension, Pulmonary
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated…
- Trial name
- EAS (NCT01784562)
- Testing
- Adempas (Riociguat, BAY63-2521)
- Where
- 102 sites in United States, Austria and 18 more
- Sponsor
- Bayer
Atrial Fibrillation
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and…
- Trial name
- NCT00950092
- Testing
- Numeris-AF Tethered Coagulation System with VisiTrax
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- nContact Surgical Inc.
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Cardiothoracic Surgery, Vascular Surgery
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery
This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.
- Trial name
- NCT01897519
- Testing
- ABT-719
- Where
- 23 sites in United States, Denmark
- Volunteers
- 56 people
- Sponsor
- AbbVie
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Thromboembolism
REVIparin-BRIDging-in a General Practice Setting in GErmany
In view of the fact that little is known about the pre- and post-interventional coagulation management of phenprocoumon patients with reviparin at general practices in Germany, an observational study is being initiated to…
- Trial name
- REVIBRIDGE (NCT02579122)
- Where
- 11 sites in Germany
- Volunteers
- 77 people
- Sponsor
- Mylan Inc.
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
Coagulation Protein Disorders, Blood Loss, Surgical
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).
- Conditions
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- Trial name
- NCT01053169
- Testing
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Where
- 6 sites in United Kingdom
- Volunteers
- 445 people
- Sponsor
- CSL Behring
Complications
Femoral Micropuncture or Routine Introducer Study
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood…
- Trial name
- FEMORIS (NCT01103141)
- Testing
- Micropuncture needle set, Standard gauge-18 needle set
- Where
- 2 sites in United States
- Volunteers
- 143 people
- Sponsor
- Cook Group Incorporated
Elevated Cardiac Risk, Coronary Arteries Disease Risk
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with…
- Trial name
- CARVASAXe (NCT01120405)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in France
- Volunteers
- 600 people
- Sponsor
- Air Liquide Santé International
Procedural Sedation
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation.
- Trial name
- NCT00327392
- Testing
- AQUAVAN® (fospropofol disodium) Injection
- Where
- 15 sites in United States
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
Cranial Aneurysm
Navigation Support With Mixed Reality With CORTEXPLORER MED
During the last 15 years, neuronavigation has become an essential neurosurgical tool for pursuing minimal invasiveness and safety.
- Trial name
- CXmed (NCT05269498)
- Testing
- CORTEXPLORER MED
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- cortEXplore GmbH
Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Fibrin Sealant Vascular Surgery Study
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants…
- Trial name
- NCT00576420
- Testing
- FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time, Manual compression with surgical gauze pads
- Where
- 11 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Venous Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c.
- Trial name
- SAVE-ABDO (NCT00679588)
- Testing
- Semuloparin Sodium, Enoxaparin sodium
- Where
- 270 sites in United States, Argentina and 37 more
- Volunteers
- 4,413 people
- Sponsor
- Sanofi
Surgery
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.
- Trial name
- Annexa-S (NCT04233073)
- Testing
- andexanet alfa
- Where
- 56 sites in United States, Austria and 4 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Peripheral Vascular Disease, Hemorrhage
The Evicel Post-Authorization Surveillance Study
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
- Trial name
- NCT01158261
- Testing
- EVICEL ™ Fibrin Sealant (Human)
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Ethicon, Inc.
Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery
Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.
- Trial name
- NCT01444235
- Testing
- Custodiol-N, Custodiol
- Where
- 4 sites in Germany
- Volunteers
- 102 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Stroke
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual…
- Trial name
- NCT00962702
- Testing
- LAAx TigerPaw System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- LAAx, Inc.