Clinical trials: Intravascular Lithotripsy
Iliac Disease, Aortic Valve Stenosis
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic…
- Trial name
- ILIT (NCT05862558)
- Testing
- Shockwave Balloon
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
Coronary Artery Disease, Severe Coronary Artery Disease
Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after…
- Conditions
- Coronary Artery Disease, Severe Coronary Artery Disease, Coronary Artery Calcification
- Trial name
- LOCATION (NCT07388030)
- Testing
- IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation, Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation
- Where
- China
- Volunteers
- 3,060 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
PAD - Peripheral Arterial Disease, PAD
Distrupt Stiffness Trial
Typical symptoms of PAD include exercise-induced pain in the legs (known as intermittent claudication), which can significantly limit pain-free walking. In more advanced stages, pain may also occur at rest.
- Trial name
- NCT07130526
- Testing
- Intravascular Lithotripsy (IVL) plus DCB, POBA plus DCB
- Where
- 2 sites in Germany
- Volunteers
- 40 people
- Sponsor
- University Hospital, Essen
Peripheral Arterial Disease
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
- Trial name
- POWER-PAD-1 (NCT05192473)
- Testing
- Pulse Intravascular Lithotripsy System
- Where
- 3 sites in Australia, Dominican Republic and 1 more
- Volunteers
- 9 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Coronary Artery Disease
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting…
- Trial name
- DEBSCAN-IVL (NCT06657833)
- Testing
- Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon, Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
- Where
- 15 sites in Netherlands, Spain
- Volunteers
- 128 people
- Sponsor
- Fundación EPIC
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-Femoral Stenting (SKYWARD Trans-Femoral 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-Femoral stenting (SKYWARD Trans-Femoral…
- Trial name
- SKYWARD TF (NCT07512128)
- Testing
- Carotid Intravascular Lithotripsy
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Calcification, Intravascular Lithotripsy
Prognostic Impact of Coronary Microvascular Dysfunction After IVL Versus RA in Patients With Severe Coronary Calcification Undergoing PCI
The goal of this observational study is to lean that whether the distinct mechanisms by which intravascular lithotripsy (IVL) and rotational atherectomy (RA) treat severe coronary calcification differentially affect the…
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Coronary Microcirculation Dysfunction
- Trial name
- NCT07699965
- Where
- China
- Volunteers
- 590 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Peripheral Arterial Disease, Critical Limb-Threatening Ischaemia
Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions…
- Trial name
- LEGACY (NCT05755412)
- Where
- 6 sites in Italy
- Volunteers
- 9 people
- Sponsor
- EndoCore Lab s.r.l.
Safety Issues, Efficacy, Self
The Lower Silesia Shockwave Registry
Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two…
- Trial name
- LSSR (NCT05916898)
- Testing
- PCI with support of Shockwave Intravascular Lithotripsy
- Where
- 2 sites in Poland
- Volunteers
- 400 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Calcified Coronary Lesions
Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)
This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
- Trial name
- COCALP (NCT06787547)
- Testing
- IVL(Sonico-CX)
- Where
- 11 sites in China
- Volunteers
- 266 people
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
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, 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 Artery Calcification
Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions
The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.
- Trial name
- CCS (NCT04428177)
- Testing
- Intravascular lithotripsy, Standart therapy
- Where
- Czechia
- Volunteers
- 40 people
- Sponsor
- University Hospital Ostrava
Coronary Artery Disease
Atherectomy vs Intravascular Lithotripsy
Preliminary experiences show that IVL is promising for achieving an effective plaque modification at time of PCI. However, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no…
- Trial name
- RAINBOW (NCT04013906)
- Testing
- Rotational atherectomy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
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.
Coronary Artery Calcification
Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT
The goal of this observational, prospective, multicenter study is to explore local action of coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with OCT, in patients with coronary artery…
- Trial name
- SCALPO (NCT05973994)
- Testing
- intravascular lithotripsy with Shockwave coronary system
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Rome Tor Vergata
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.
Coronary Arterial Disease (CAD), Coronary Calcification
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN)…
- Conditions
- Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules, Orbital Atherectomy
- Trial name
- ORBIT-SHOCK (NCT06736665)
- Testing
- Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT)
- Where
- 6 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Spanish Society of Cardiology
Coronary Artery Disease, Calcification
Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions
Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of Intravascular Lithotripsy (IVL) compared to Rotational Atherectomy (RA) treatment in calcified coronary lesions
- Trial name
- DECALCIFY (NCT04960319)
- Testing
- Intravascular Lithotripsy
- Volunteers
- 100 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study. The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave…
- Conditions
- Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture
- Trial name
- TEVAR (NCT06332911)
- Testing
- Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 30 people
- Sponsor
- Rede Optimus Hospitalar SA