Clinical trials: Vascular Surgery
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Arthritis, Osteoarthritis, Knee
Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement
The study will describe the short-term effects the study drug, rivaroxaban, has on the body when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by mouth) for the prevention of blood clotting in…
- Conditions
- Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Thromboembolism
- Trial name
- NCT01094886
- Testing
- Rivaroxaban
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
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
Blood Loss, Surgical
Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and…
- Trial name
- NCT03152461
- Testing
- Quantra System
- Where
- 4 sites in United States
- Volunteers
- 302 people
- Sponsor
- HemoSonics LLC
Coronary Artery Disease
Photochemical Tissue Passivation Treatment of Saphenous Vein Grafts in CABG
Early feasibility study of the DurVena Photochemical Tissue Passivation (PTP) device for treatment of saphenous vein grafts in participants undergoing elective coronary artery bypass graft (CABG) surgery.
- Trial name
- NCT06150872
- Testing
- DurVena Photochemical Tissue Passivation
- Where
- Uzbekistan
- Volunteers
- 4 people
- Sponsor
- DurVena, Inc.
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Coronary Disease
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
- Trial name
- RECON (NCT02073331)
- Where
- 43 sites in United States
- Volunteers
- 1,420 people
- Sponsor
- Elutia Inc.
Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair
GLYCAR Post Market Multicenter Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Trial name
- CIP002 (NCT05661981)
- Testing
- GLYCAR Pericardial Patch
- Where
- 4 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- GLYCAR SA (Pty) Ltd
Coronary Artery Disease
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass…
- Trial name
- NCT00042081
- Testing
- CGT003 (E2F Duplex Decoy)
- Where
- 154 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Anesiva, Inc.
Venous Leg Ulcer
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R).
- Trial name
- DEVO (NCT00909870)
- Testing
- Dermagraft(R), Profore
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 537 people
- Sponsor
- Organogenesis
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
Diabetic Foot Ulcers, Diabetic Foot Wounds
Using Santyl on Diabetic Foot Ulcers
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound.
- Trial name
- NCT01408277
- Testing
- Santyl, Control
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Healthpoint
Venous Thromboembolism, Embolism and Thrombosis
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
- Conditions
- Venous Thromboembolism, Embolism and Thrombosis, Hip Fractures
- Trial name
- NCT00119457
- Testing
- TTP889
- Where
- 21 sites in Czechia, Denmark and 2 more
- Volunteers
- 300 people
- Sponsor
- vTv Therapeutics
Intracerebral Hemorrhage, Brain Hemorrhage
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular…
- Conditions
- Intracerebral Hemorrhage, Brain Hemorrhage, Intraventricular Hemorrhage
- Trial name
- PRONTO (NCT04178746)
- Testing
- Artemis Neuro Evacuation Device
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Penumbra Inc.
Venous Thromboembolism
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
- Trial name
- NCT01181141
- Testing
- DU-176b (edoxaban), Enoxaparin sodium 20mg
- Where
- Japan
- Volunteers
- 92 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Coronary Heart Disease, Graft Occlusion, Vascular
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG)…
- Trial name
- NCT01245634
- Testing
- RO4905417
- Where
- 38 sites in United States, Canada
- Volunteers
- 384 people
- Sponsor
- Hoffmann-La Roche
Coronary Artery Disease
Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery
The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta…
- Trial name
- EPIC (NCT00355563)
- Testing
- PAS-Port Automated Proximal Anastomosis System
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Cardica, Inc
Surgical Site Infection, Thrombosis
Tumescent Anesthesia Antibiotic Delivery (TAAD)
This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food \& Drug Administration (FDA) has approved our…
- Conditions
- Surgical Site Infection, Thrombosis, Sepsis
- Trial name
- TAAD (NCT03226626)
- Testing
- Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD, SubQKath
- Volunteers
- 330 people
- Sponsor
- HK Surgical, Inc.
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH