Clinical trials: Peripheral Artery Calcification
Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases
Immunomodulatory Effects of PCSK9 Inhibition
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also…
- Conditions
- Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Atherosclerosis, Arterial Inflammation
- Trial name
- INSPIRAR (NCT05720156)
- Testing
- 99mTc-tilmanocept SPECT/CT scanning
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Peripheral Arterial Disease, Claudication, Intermittent
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac…
- Conditions
- Peripheral Arterial Disease, Claudication, Intermittent, Claudication, PAD
- Trial name
- AIIRES (NCT03590769)
- Testing
- 18F-FDG
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of California, San Francisco
Aortic Diseases, Aorto-Iliac Atherosclerosis
Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices…
- Conditions
- Aortic Diseases, Aorto-Iliac Atherosclerosis, Peripheral Arterial Disease
- Trial name
- SHOCK-ACCESS (NCT05880641)
- Where
- 6 sites in Italy
- Volunteers
- 40 people
- Sponsor
- EndoCore Lab s.r.l.
Peripheral Artery Disease, Peripheral Artery Stenosis
The THOR IDE Study
The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
- Conditions
- Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
- Trial name
- THOR (NCT05916950)
- Testing
- Thor laser atherectomy
- Where
- 29 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Peripheral Arterial Disease
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease.
- Trial name
- MODIFY (NCT03268018)
- Testing
- Laser induced pressure wave calcium modification
- Where
- 2 sites in Belgium
- Volunteers
- 8 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified…
- Trial name
- NCT00733135
- Testing
- SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
- Volunteers
- 133 people
- Sponsor
- Medtronic Endovascular
Post-COVID-19 Condition, Ulcerative Colitis
Emerging Indications for Hyperbaric Oxygen Treatment
This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric…
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis
- Trial name
- NCT07240649
- Testing
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Volunteers
- 100 people
- Sponsor
- Jay C. Buckey Jr.
Peripheral Arterial Disease
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease.
- Trial name
- STRIKE (NCT06636968)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
Peripheral Arterial Disease, Vascular Disease, Peripheral
Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System
Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.
- Trial name
- Disrupt PAD+ (NCT04585763)
- Testing
- Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 37 people
- Sponsor
- Shockwave Medical, Inc.
End-stage Renal Disease, Hemodialysis
The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients
Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it.
- Conditions
- End-stage Renal Disease, Hemodialysis, Aortic Calcification, Peripheral Artery Occlusion
- Trial name
- NCT01945255
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- National Taiwan University Hospital
Peripheral Arterial Disease
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard…
- Trial name
- CRACK-IT (NCT06112171)
- Testing
- Intravascular lithotripsy, Standard lesion preparation
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Peripheral Artery Disease, End Stage Renal Disease on Dialysis
A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.
- Trial name
- NCT04487301
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sanifit Therapeutics S. A.
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Arterial Disease (PAD)
Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™)…
- Trial name
- POWER PAD 2 (NCT06457685)
- Testing
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Where
- 19 sites in United States
- Volunteers
- 115 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Peripheral Artery Disease (PAD)
A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled…
- Trial name
- SPARC (NCT07209085)
- Testing
- FastWave Artero™ Peripheral IVL System
- Volunteers
- 110 people
- Sponsor
- FastWave Medical
Femoral Arterial Calcification, Peripheral Arterial Disease
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of…
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT05145478
- Testing
- Shockwave Intravascular Lithotripsy (IVL)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Patients With Peripheral Artery Calcified Lesions
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Trial Evaluating the Safety and Efficacy of Single-use Peripheral Intravascular Shock Wave Catheters Combined With Intravascular Shock Wave Therapy Devices for Peripheral Artery Calcified Lesions.
This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the…
- Trial name
- NCT07839143
- Testing
- Interventional therapy in the experimental group, Interventional therapy in the control group
- Volunteers
- 158 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Peripheral Vascular Disease
DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg.
- Trial name
- REALITY (NCT02850107)
- Testing
- Medtronic HawkOne® or TurboHawk™, Medtronic IN.PACT® Admiral® DCB, Medtronic Spider™ Distal Protection Device (DPD)
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- VIVA Physicians
Peripheral Artery Disease
3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were…
- Trial name
- FIDJI (NCT06173960)
- Testing
- atherectomy
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique
End-stage Renal Disease, Peritoneal Dialysis
The Relationship Between Aortic Pulse Wave, Aortic Calcification and Peripheral Artery Occlusion Disease in Peritoneal Dialysis Patients
Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it.
- Conditions
- End-stage Renal Disease, Peritoneal Dialysis, Aortic Calcification, Peripheral Artery Occlusion
- Trial name
- NCT01945203
- Where
- Taiwan
- Volunteers
- 174 people
- Sponsor
- National Taiwan University Hospital