Clinical trials: Calcinosis
Coronary Artery Calcification
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05818098
- Testing
- Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
Calcified Aortic Valve
A Prospective RegistrY of Cardiac Echographic Loops
CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e.
- Trial name
- ARYEL (NCT03371524)
- Testing
- Cardiac Echography
- Where
- 3 sites in France
- Volunteers
- 90 people
- Sponsor
- Cardiawave SA
Catheter Infection, Catheter Blockage
Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially…
- Conditions
- Catheter Infection, Catheter Blockage, Catheter Related Complication, Catheter Calcification
- Trial name
- NCT05931887
- Testing
- SILQ ClearTract 100% Silicone 2-Way Foley Catheter
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Silq Technologies 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
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Primary Coronary Artery Calcification
SoniCrackerTM Single-use Intracoronary Shockwave Catheter
This study aims to observe the safety and effectiveness of the SoniCrackerTM single-use intracoronary shockwave catheter in the pretreatment and balloon dilation of primary coronary artery calcification lesions (coronary artery…
- Trial name
- NCT07873736
- Volunteers
- 390 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
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.
Calciphylaxis, Calcific Uremic Arteriolopathy
Double-blind Trial of Sodium Thiosulfate for the Treatment of Pain Associated With Calcific Uremic Arteriolopathy
To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial 28-day treatment phase.
- Trial name
- NCT02527213
- Testing
- Sodium thiosulfate
- Where
- 3 sites in United States
- Sponsor
- American Regent, Inc.
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
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Generalized Arterial Calcification of Infancy
Natural History Study of ENPP1 Deficiency and the Early-onset Form of ABCC6 Deficiency
The purpose of this prospective study is to characterize the natural history of ENPP1 Deficiency and the early-onset form of ABCC6 Deficiency longitudinally.
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Generalized Arterial Calcification of Infancy, Autosomal Recessive Hypophosphatemic Rickets, Adenosine Triphosphate Binding Cassette Transporter Protein Subfamily C Member 6
- Trial name
- NCT05050669
- Testing
- No Intervention for this observational study
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 12 people
- Sponsor
- Inozyme Pharma
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency
Natural History Study: ENPP1 Deficiency or the Early-Onset Form of ABCC6 Deficiency
The purpose of this study is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) Deficiency and the early-onset form of adenosine triphosphate binding cassette transporter subfamily C…
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency, Generalized Arterial Calcification of Infancy, Autosomal Recessive Hypophosphatemic Rickets
- Trial name
- NCT07745179
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 23 people
- Sponsor
- Inozyme Pharma
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets
ENERGY 2: Evaluation of the Efficacy and Safety of INZ-701 in Infants With ENPP1 Deficiency
The primary purpose of ENERGY 2 (Study INZ701-105) is to assess the efficacy and safety of INZ-701 in infants with ENPP1 Deficiency.
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy 1
- Trial name
- NCT07473973
- Testing
- INZ-701
- Where
- 8 sites in Brazil, France and 6 more
- Volunteers
- 2 people
- Sponsor
- Inozyme Pharma
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
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
Calciphylaxis
A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic…
- Trial name
- CALISTA (NCT03150420)
- Testing
- Sodium Thiosulfate
- Where
- 21 sites in United States, Canada and 1 more
- Volunteers
- 29 people
- Sponsor
- Hope Pharmaceuticals
Calciphylaxis
SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic…
- Trial name
- SEAPORT 1 (NCT06283589)
- Testing
- INZ-701
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Inozyme Pharma
Coronary Artery Disease, Coronary Artery Calcification
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.
- Trial name
- FRACTURE (NCT06181240)
- Testing
- Intravascular lithotripsy
- Where
- 46 sites in United States, Belgium and 5 more
- Volunteers
- 426 people
- Sponsor
- Bolt Medical
Coronary Artery Disease, Calcification
Post-Marketing Clinical Study of High-Pressure Cutting Balloon
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation.
- Trial name
- NCT07835178
- Testing
- High pressure cutting balloon, Non-cutting balloon
- Where
- China
- Volunteers
- 280 people
- Sponsor
- BrosMed Medical Co., Ltd
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation