Clinical trials: Calcifications, Vascular
Chronic Kidney Disease, End Stage Renal Disease
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification
- Trial name
- NCT00379899
- Testing
- cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
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
Coronary Artery Disease
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: A composite of MACE at 30-day and one (1) year post procedure, and…
- Trial name
- MACE (NCT01930214)
- Testing
- Percutaneous Coronary Intervention
- Where
- 34 sites in United States
- Volunteers
- 350 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Calcifications Vascular
SOLSTICE Trial in China
This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions…
- Trial name
- NCT05433376
- Testing
- Shockwave Coronary Intravascular Lithotripsy (IVL) System C2
- Where
- 3 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Coronary Stenosis
Shockwave Coronary Lithoplasty Study
The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave…
- Trial name
- NCT02758379
- Testing
- Shockwave Coronary Lithoplasty System
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Disease
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
- Trial name
- EMPOWER CAD (NCT05755711)
- Testing
- Shockwave Medical Coronary IVL System
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 399 people
- Sponsor
- Shockwave Medical, Inc.
Gene Mutations, Pseudoxanthoma Elasticum
ADAPT Study: Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
The purpose of this study (Study INZ701-304 [ADAPT]) is to assess the long-term safety of INZ-701 in patients with ENPP1 Deficiency or ABCC6 Deficiency who have received INZ-701 in an existing clinical study and choose to…
- Conditions
- Gene Mutations, Pseudoxanthoma Elasticum, Arterial Calcification, Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency
- Trial name
- NCT06462547
- Testing
- INZ-701
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 22 people
- Sponsor
- Inozyme Pharma
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.
Coronary Artery Disease (CAD), Stenosis Coronary
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease
- Trial name
- PCI EVOlution (NCT07491107)
- Testing
- Inspiron EVO Drug-Eluting Stent
- Where
- Brazil
- Volunteers
- 2,000 people
- Sponsor
- Scitech Produtos Medicos SA
Pseudoxanthoma Elasticum
Pseudoxanthoma Elasticum (PXE) Natural History Biomarkers in PXE Individuals and Their Biological Non-PXE Siblings
This PXE biomarker study aims to characterize the levels of inorganic pyrophosphate (PPi), pyridoxal 5´-phosphate (PLP), and other biomarkers relevant to PXE and ectopic calcification in both PXE patients and their biological…
- Trial name
- NCT05025722
- Testing
- Non Interventional
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
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
Coronary Artery Calcification, Coronary Artery Disease
TECTONIC CAD IVL IDE Study
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion
- Trial name
- TECTONIC (NCT06885177)
- Testing
- Experimental
- Where
- 40 sites in United States
- Volunteers
- 335 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the…
- Trial name
- NCT02650128
- Testing
- Shockwave Coronary Rx Lithoplasty® System
- Where
- 7 sites in Australia, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Myocardial Infarction
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo…
- Trial name
- NCT05966662
- Testing
- IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
- Where
- 18 sites in United States
- Volunteers
- 145 people
- Sponsor
- Shockwave Medical, Inc.
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Coronary Artery Disease
BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
- Trial name
- NCT07010094
- Testing
- BM shockwave devices
- Where
- China
- Volunteers
- 198 people
- Sponsor
- BrosMed Medical Co., Ltd
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease, Hypercholesterolemia
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled…
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
- Trial name
- NCT07803679
- Testing
- Evolocumab, Routine Lipid Management, Autoinjector
- Volunteers
- 308 people
- Sponsor
- Amgen