Clinical trials: Vascular Calcification
Peripheral Arterial Disease
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to…
- Trial name
- NCT02923193
- Testing
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 306 people
- Sponsor
- Shockwave Medical, Inc.
Multiple Myeloma
Velcade Consolidation Bone Study
The purpose of this study is to assess the effect of bortezomib on myeloma-related bone disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who have received high dose chemotherapy and autologous…
- Trial name
- NCT01286077
- Testing
- bortezomib
- Where
- 21 sites in Austria, Czechia and 6 more
- Volunteers
- 106 people
- Sponsor
- Janssen-Cilag International NV
Cardiovascular Diseases, Cardiovascular Abnormalities
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease
- Trial name
- NCT02966028
- Testing
- SNF472
- Where
- 75 sites in United States, Spain and 1 more
- Volunteers
- 274 people
- Sponsor
- Sanifit Therapeutics S. A.
Chronic Kidney Disease
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range…
- Trial name
- NCT00785629
- Testing
- Calcium acetate, Lanthanum Carbonate, Sevelamer Carbonate
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Denver Nephrologists, P.C.
Vascular Calcification
Effect of Citrate Dialysate on Vascular Calcification
The goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without…
- Trial name
- NCT04956120
- Testing
- Citrate Dialysate, Standard Dialysate
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- Emory University
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD IV With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries…
- Trial name
- NCT04151628
- Testing
- Lithotripsy
- Where
- 8 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Shockwave Medical, Inc.
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 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
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, Kidney Transplantation
Bone Mass and Strength After Kidney Transplantation
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
- Conditions
- End Stage Renal Disease, Kidney Transplantation, Bone Loss, Fractures
- Trial name
- NCT02224144
- Testing
- Vitamin D3, Calcitriol
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Columbia University
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.
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.
Hyperparathyroidism, Secondary
Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients
Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation.
- Trial name
- PAD (NCT00646282)
- Testing
- doxercalciferol
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Coronary Artery Disease
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects.
- Trial name
- ORBIT II (NCT01092416)
- Testing
- Diamondback 360 Orbital Atherectomy System
- Where
- 51 sites in United States
- Volunteers
- 443 people
- Sponsor
- Abbott Medical Devices
Peripheral Artery Disease
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.
- Trial name
- NCT05007925
- Testing
- Intravascular Lithotripsy
- Where
- 43 sites in United States, Germany
- Volunteers
- 250 people
- Sponsor
- Shockwave Medical, Inc.
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
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 Atherosclerosis, Coronary Artery Calcification
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress.
- Conditions
- Coronary Atherosclerosis, Coronary Artery Calcification, Coronary Stenosis
- Trial name
- NCT00860847
- Testing
- Aged garlic extract and Coenzyme Q10
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center