Clinical trials: sponsored by C. R. Bard
Femoral Artery Stenosis, Popliteal Artery Stenosis
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- CONFIRM (NCT02813577)
- Testing
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
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
Peripheral Artery Disease
LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.
- Trial name
- NCT01628159
- Testing
- Lutonix Drug Coated Balloon
- Where
- 64 sites in United States, Austria and 3 more
- Volunteers
- 657 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the…
- Trial name
- BTKRegistry (NCT02554266)
- Testing
- Lutonix 014 Drug Coated Balloon PTA Catheter
- Where
- 26 sites in Austria, Belgium and 9 more
- Volunteers
- 371 people
- Sponsor
- C. R. Bard
Superficial Femoral Artery Stenosis
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent®…
- Trial name
- CONTINUUM (NCT00908947)
- Testing
- PTA followed by placement of LifeStent® Vascular Stent
- Where
- 29 sites in United States
- Volunteers
- 173 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions…
- Trial name
- NCT02278991
- Testing
- Lutonix Drug Coated Balloon
- Where
- 12 sites in Germany, Greece and 1 more
- Volunteers
- 149 people
- Sponsor
- C. R. Bard
Femoral Artery Occlusion, Femoral Arterial Stenosis
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
- Trial name
- NCT02013271
- Testing
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
- Where
- 14 sites in Austria, Belgium and 3 more
- Volunteers
- 125 people
- Sponsor
- C. R. Bard
Arterial Occlusive Disease
A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients
The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.
- Trial name
- Reliable (NCT01746550)
- Testing
- MD-12-001 Stent
- Where
- 12 sites in Japan
- Volunteers
- 70 people
- Sponsor
- C. R. Bard
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Peripheral Vascular Disease
Bard® LifeStent® Vascular Stent Delivery System Study
The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
- Trial name
- NCT01179984
- Testing
- Bard® LifeStent® Vascular Stent System
- Where
- 8 sites in Austria, Germany
- Volunteers
- 76 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Intermittent Claudication
Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System
The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD).
- Trial name
- REALITY III (NCT03071146)
- Testing
- Bard® LifeStent® 5F Vascular Stent System
- Where
- 4 sites in Germany
- Volunteers
- 30 people
- Sponsor
- C. R. Bard
Ventral Hernia, Incisional Hernia
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
- Trial name
- NCT02053168
- Testing
- Resorbable Mesh
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- C. R. Bard
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Primary Focus: Adult Subjects Who Require PICC Placement
Electrocardiogram (ECG) Guided Peripherally Inserted Central Catheter (PICC) Placement
This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines. There is no formal study hypothesis.
- Trial name
- NCT00742053
- Testing
- ECG-guided PICC placement
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- C. R. Bard
Intermittent Claudication, Atherosclerotic Disease
Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral…
- Conditions
- Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease
- Trial name
- RESILIENT (NCT00673985)
- Testing
- Percutaneous Transluminal Angioplasty, LifeStent NT™ Self-Expanding Peripheral Stent
- Volunteers
- 246 people
- Sponsor
- C. R. Bard
Vascular Access Complication
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01937195
- Testing
- AccuCath Intravenous Catheter System
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- C. R. Bard
Vascular Access Complication
Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the…
- Trial name
- NCT02449798
- Testing
- AccuCath 2.25" BC Intravascular Catheter
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard
Vascular Access Complication
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
- Trial name
- NCT00914069
- Testing
- RIVS vascular access, Conventional vascular access
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Indication for PICC Placement
Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation
The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).
- Trial name
- NCT02498821
- Testing
- Chest X-ray, Sherlock 3CG® TCS, Peripherally Inserted Central Catheter (PICC)
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard