Clinical trials: Chronic Venous Insufficiency
End Stage Renal Disease, Vascular Access Patency
Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis
This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited.
- Trial name
- NCT02335099
- Testing
- ticagrelor
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Virginia
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Lymphedema
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic…
- Trial name
- NCT01079299
- Testing
- Intermittent, gradient, pneumatic compression device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Calvary Hospital, Bronx, NY
Chronic Venous Insufficiency
Venclose RF Ablation System for the Treatment of IPVs
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
- Trial name
- NCT04386785
- Testing
- Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Venclose, Inc.
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Venous Ulcer, Venous Stasis Ulcer
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Conditions
- Venous Ulcer, Venous Stasis Ulcer, Ulcer
- Trial name
- NCT01853384
- Testing
- HP802-247, HP802-247 Vehicle
- Where
- 46 sites in Belgium, Czechia and 3 more
- Volunteers
- 252 people
- Sponsor
- Healthpoint
Chronic Venous Insufficiency
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance…
- Trial name
- NCT05051540
- Testing
- Sigvaris Compreflex Inelastic Compression Wrap
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Miami
End Stage Renal Disease, AV Fistula
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Trial name
- SAVE (NCT01471041)
- Testing
- Venous Window Needle Guide
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Vital Access Corp.
Chronic Venous Insufficiency
Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
The purpose of this study is to evaluate the efficacy and safety of the fixed-dose combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic venous insufficiency.
- Trial name
- NCT01848210
- Testing
- Coumarin/troxerutin
- Volunteers
- 829 people
- Sponsor
- Takeda
Venous Hypertension Ulcers, Venous Stasis Ulcer
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers.
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Trial name
- MUSTCOOL (NCT02626156)
- Testing
- Cooling gel pack, Cooling cotton pack
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medical University of South Carolina
Chronic Venous Insufficiency
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
- Trial name
- INFINITE-OUS (NCT03216005)
- Testing
- BlueLeaf System
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Intervene, Inc.
Deep Vein Thrombosis, Post-thrombotic Syndrome
Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System
To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic® Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome from chronic venous occlusion.
- Trial name
- ACCESS PTS (NCT02159521)
- Testing
- EkoSonic® Endovascular System, Alteplase
- Where
- 22 sites in United States
- Volunteers
- 81 people
- Sponsor
- Boston Scientific Corporation
Chronic Venous Insufficiency (CVI), Deep Vein Reflux
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic chronic venous insufficiency (CVI) of the lower extremity
- Trial name
- INFINITE-US (NCT04225806)
- Testing
- BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Intervene, Inc.
Venous Leg Ulcer, Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer
- Trial name
- NCT02395302
- Testing
- Dual Action Pneumatic Compression
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Tactile Medical
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeVA (NCT02790606)
- Testing
- Covera(TM) Vascular Covered Stent
- Where
- 16 sites in United States
- Volunteers
- 110 people
- Sponsor
- C. R. Bard
Chronic Venous Insufficiency
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and…
- Trial name
- NCT02236338
- Testing
- Ablation of the Incompetent Greater Saphenous Vein, ClosureFAST radiofrequency catheter, EVLT 980nm diode laser system
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Virginia Commonwealth University
End Stage Kidney Disease, Chronic Kidney Diseases
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in…
- Conditions
- End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency
- Trial name
- WAVE-Global (NCT04626427)
- Testing
- WavelinQ™ EndoAVF System
- Where
- 3 sites in Belgium, Greece and 1 more
- Volunteers
- 21 people
- Sponsor
- C. R. Bard
Lymphedema, Lymphedema Lower Extremity
Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
- Conditions
- Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema
- Trial name
- TIBER (NCT04897035)
- Testing
- Dayspring Active Wearable Compression System
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Koya Medical, Inc.
Chronic Venous Insufficiency
VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)
The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6.
- Trial name
- VAP-PRO-C6 (NCT04757766)
- Testing
- in daily everyday routine practice
- Where
- Russia
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Servier Russia