Clinical trials: Calcifications Vascular
Aortic Aneurysm
Validation of a Software and the Follow-up of Anteropoterior Migration of Stent
The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure.
- Trial name
- ASMOT (NCT05287828)
- Testing
- Surgeons CT scan analysis, PRAEVAorta CT scan analysis
- Where
- France
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Nurea
Coronary Artery Disease, Intravascular Lithotripsy
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China.
- Trial name
- NCT05649488
- Testing
- Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus, Dragonfly Opstar Imaging Catheter
- Where
- 20 sites in China
- Volunteers
- 184 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
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
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific 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
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
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
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
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 Arterial Disease (CAD)
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment…
- Trial name
- POWER CAD I (NCT07510438)
- Testing
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 15 people
- Sponsor
- Amplitude Vascular Systems, Inc.
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
Carotid Artery Calcification, Carotid Artery Diseases
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid…
- Trial name
- NCT07062471
- Testing
- Carotid Intravascular Lithotripsy (IVL)
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Carotid Artery Stenosis
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
Clinical Trial Summary Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Trial name
- CREATE (NCT06936176)
- Testing
- Neurovascular Intravascular Shockwave Catheter
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
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
PAD, Vascular Calcification
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of…
- Trial name
- OPTIMIZE BTK (NCT02561299)
- Testing
- Peripheral Orbital Atherectomy System, 014 Drug Coated Balloon
- Where
- 7 sites in Austria, Germany
- Volunteers
- 66 people
- Sponsor
- Abbott Medical Devices
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, 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
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, 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.