Clinical trials: Vascular Surgical Procedures
Aneurysm, Dissection
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
- Conditions
- Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection
- Trial name
- PANTHER (NCT04545502)
- Testing
- Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch
- Where
- 30 sites in United States, Belgium and 4 more
- Volunteers
- 2,000 people
- Sponsor
- Vascutek Ltd.
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Reconstructive Surgical Procedures, Plastic Surgery
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Trial name
- IMED-GLOW800 (NCT07164040)
- Testing
- The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
- Where
- 3 sites in Portugal, Spain and 1 more
- Volunteers
- 31 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Oedema, Neuropathy
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy
- Trial name
- TURBO (NCT02316210)
- Testing
- electrical stimulation
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Firstkind Ltd
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
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
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Embolism
Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients
Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism.
- Trial name
- NCT00311753
- Testing
- Certoparin, Heparin
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 342 people
- Sponsor
- Novartis Pharmaceuticals
Vascular Disease
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels…
- Trial name
- StEPS (NCT00759681)
- Testing
- ArterX Surgical Sealant, Gelfoam and Thrombin
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Tenaxis Medical, Inc.
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
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
Target Bleeding Site During Peripheral Vascular Surgery
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
- Trial name
- NCT00684047
- Testing
- FS Grifols, Manual Compression
- Where
- 19 sites in Canada, Spain and 1 more
- Volunteers
- 239 people
- Sponsor
- Instituto Grifols, S.A.
Spinal Surgery, Vascular Surgery
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
- Trial name
- NCT00491608
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- ZymoGenetics
Percutaneous Coronary Intervention, Coronary Heart Disease
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery.
- Conditions
- Percutaneous Coronary Intervention, Coronary Heart Disease, Robotic Surgical Procedures
- Trial name
- NCT05642286
- Testing
- ALLVAS® robotic-assisted PCI
- Volunteers
- 218 people
- Sponsor
- Shanghai Operation Robot Co., Ltd.
Postoperative Complications, Memory Disorders
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic…
- Trial name
- NCT00736125
- Testing
- pulsatile saline lavage, carbon dioxide lavage
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Kinamed Incorporated
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
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
Surgical Wound Healing, Lower Extremity
Oxygen for Vascular Incisional Healing
The purpose of this clinical trial is to evaluate Transdermal Continuous Oxygen Therapy (TCOT) as an adjunct to surgical wound healing in subjects undergoing vascular surgery for lower extremity arterial occlusive disease.
- Conditions
- Surgical Wound Healing, Lower Extremity, Revascularization, Incision
- Trial name
- NCT03746132
- Testing
- EPIFLO
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neogenix, LLC dba Ogenix