Clinical trials: PTA
Peripheral Artery Disease, Peripheral Vascular Disease
The VaSecure BTK Study
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease
- Trial name
- NCT03638115
- Testing
- VaSecure™
- Where
- 7 sites in Belgium, Germany and 1 more
- Volunteers
- 46 people
- Sponsor
- Vascuros Medical Pte Ltd
Healthy Volunteers
Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants
This study is researching experimental drugs called REGN9933 and REGN7508 (called "study drugs") and comparing their effects to approved treatments of rivaroxaban and aspirin (called "standard treatments").
- Trial name
- NCT06444178
- Testing
- Aspirin, REGN9933, REGN7508
- Where
- United Kingdom
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Chronic Limb Ischemia
Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization
This is a prospective, multi-center, randomized pilot study to document the effects of adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in symptomatic patients with critical limb ischemia…
- Trial name
- LIMBO-PTA (NCT02479555)
- Testing
- Dexamethasone sodium phosphate injection, USP, 4 mg/mL
- Where
- 3 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Mercator MedSystems, Inc.
Dysfunctional AV Graft, Dysfunctional AV Fistula
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.
- Trial name
- ACCESS (NCT02183194)
- Testing
- Lutonix Paclitaxel Drug Coated Balloon
- Where
- 4 sites in Austria, Germany
- Sponsor
- C. R. Bard
PAD
Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)
This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic…
- Trial name
- DCB (NCT02907203)
- Testing
- Drug Coated Balloon
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- W.L.Gore & Associates
Renal Artery Obstruction, Hypertension, Renal
The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis
The purpose of this study is to determine whether the Herculink Elite Renal Stent System is safe and effective in the treatment of renal artery stenosis in patients with less than optimal angioplasty results and uncontrolled…
- Trial name
- HERCULES (NCT00490841)
- Testing
- Herculink Elite Renal Stent System
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Critical Limb Ischemia
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs.
- Trial name
- SAVAL (NCT03551496)
- Testing
- Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 201 people
- Sponsor
- Boston Scientific Corporation
Infrainguinal Peripheral Arterial Disease
Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters.
- Trial name
- NCT02237066
- Testing
- Chocolate PTA Balloon Angioplasty, Standard PTA Balloon Angioplasty
- Where
- 2 sites in United States
- Sponsor
- TriReme Medical, LLC
Peripheral Arterial Disease (PAD)
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug…
- Trial name
- INPACT SFA I (NCT01175850)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- Germany
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Recovery of Lactobacillus Reuteri ATCC PTA 4659, The Safety of Lactobacillus Reuteri ATCC PTA 4659
To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14…
- Trial name
- NCT01033539
- Testing
- Probiotic strain ATCC PTA 4659
- Where
- Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Good Food Practice, Sweden
Peripheral Artery Disease, Claudication
Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries
The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months…
- Conditions
- Peripheral Artery Disease, Claudication, Atherosclerosis, Arteriosclerosis
- Trial name
- RANGER-SFA (NCT02013193)
- Testing
- Ranger DCB, uncoated PTA balloon
- Where
- 11 sites in Austria, France and 1 more
- Volunteers
- 105 people
- Sponsor
- Hemoteq AG
Healthy Volunteers
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers
The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants The secondary objectives of the study are to: Evaluate the effects of single doses of REGN9933 on…
- Trial name
- NCT05102136
- Testing
- REGN9933
- Where
- Belgium
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
End-stage Renal Disease (ESRD)
A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
Evaluation of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ISIS 416858 for up to 204 participants with ESRD receiving chronic hemodialysis as assessed by FXI activity reduction.
- Trial name
- EMERALD (NCT03358030)
- Testing
- ISIS 416858
- Where
- 2 sites in Spain
- Volunteers
- 213 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Peripheral (Lowr Extremity) Arterial Disease.
Rapid Exchange Devices Observational Registry.
This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.
- Trial name
- RXRegistry (NCT01994798)
- Where
- 9 sites in Belgium, Spain
- Volunteers
- 525 people
- Sponsor
- Terumo Europe N.V.
Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
VITUS Post-Market Registry
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the…
- Trial name
- NCT06832631
- Testing
- Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 283 people
- Sponsor
- OrbusNeich
Glycogen Storage Disease Type II
Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)
This long-term open label safety and efficacy study is intended to follow up, and to provide post-trial access to ERT with avalglucosidase alfa to patients with Pompe disease in France who have completed Study EFC14028, LTS13769…
- Trial name
- NCT05164055
- Testing
- Avalglucosidase alfa (GZ402666)
- Where
- 11 sites in France
- Volunteers
- 17 people
- Sponsor
- Genzyme, a Sanofi Company
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
End Stage Renal Disease Requiring Hemodialysis
Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug
Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow…
- Trial name
- RE-THINc ESRD (NCT04534114)
- Testing
- Fesomersen sodium (BAY2976217)
- Where
- 69 sites in United States, Belgium and 13 more
- Volunteers
- 307 people
- Sponsor
- Bayer
Arteriovenous Fistula
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating…
- Trial name
- NCT02440022
- Testing
- Lutonix DCB, Standard Balloon Angioplasty Catheter, Percutaneous Transluminal Angiography
- Where
- 23 sites in United States
- Volunteers
- 285 people
- Sponsor
- C. R. Bard