Clinical trials: Intravascular Lithotripsy
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Shockwave IVL + DES
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Calcifications Vascular
- Trial name
- Shockwave DES (NCT05291247)
- Testing
- Peripheral lithotripsy system (Shockwave Medical)
- Where
- 6 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Marc Bosiers, MD
Peripheral Arterial Disease
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
- Trial name
- NCT05058456
- Testing
- Shockwave Medical Mini S Peripheral IVL Catheter
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 35 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Artery Disease
IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD
To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment…
- Trial name
- HELIX-PAD-FIH (NCT07747883)
- Testing
- IV-X Medical IVL System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- IVX Medical
Coronary Calcification
IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions
This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation…
- Trial name
- NCT04556682
- Testing
- Rotational atherectomy, Intravascular lithotripsy
- Where
- Netherlands
- Volunteers
- 101 people
- Sponsor
- Assiut University
Calcified Coronary Artery Disease
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation.
- Trial name
- ISAR-CALC2 (NCT05072730)
- Testing
- Super High Pressure Balloon (OPN NC), Intravascular lithotripsy (IVL)
- Where
- 6 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Calcifications, Intravascular Lithotripsy
Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes…
- Conditions
- Coronary Artery Calcifications, Intravascular Lithotripsy, Rotational Atherectomy, Intravascular Ultrasound
- Trial name
- LIRAC (NCT07750964)
- Testing
- intravascular lithotripsy, rotational atherectomy
- Volunteers
- 190 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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.
Severely Calcified Coronary Stenoses, De Novo Stenosis
Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events…
- Trial name
- REC-CHIPCAC (NCT06238518)
- Testing
- Intravascular Lithotripsy, Conventional lesion preparation strategy
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Xijing Hospital
Coronary Artery Calcification, Intravascular Lithotripsy
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy, Stent Restenosis
- Trial name
- DRAGON (NCT06276114)
- Testing
- Stent Underexpansion
- Where
- 20 sites in Italy, Poland
- Volunteers
- 121 people
- Sponsor
- Medical University of Silesia
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.
Coronary Disease
The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry
The GISE-SHOCKCALCIUM Registry is an Investigator Driven Italian All Comers prospective, observational, multicenter Italian IVL registry of Calcified lesions Treated with Intravascular Lithotripsy.
- Trial name
- NCT05455515
- Testing
- IVL procedures
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Fondazione GISE Onlus
Chronic Limb-Threatening Ischemia
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural…
- Trial name
- CALCIO (NCT06149650)
- Testing
- Shockwave Medical IVL System
- Where
- 39 sites in Austria, Canada and 6 more
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis
Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural…
- Conditions
- Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis, Intravascular Lithotripsy; Rotational Atherectomy; OFDI, Orbital Atherectomy
- Trial name
- OROBICA (NCT07566403)
- Testing
- Percutaneous coronary intervention with or without stent implantation
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Papa Giovanni XXIII Hospital
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.
Trans-femoral TAVI With Calcified Ilio-femoral Arteries
TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
- Trial name
- TRAFIC-PTA (NCT05873842)
- Testing
- Trans-femoral TAVI
- Where
- 5 sites in Italy
- Volunteers
- 50 people
- Sponsor
- Rede Optimus Hospitalar SA
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.
Femoral Arterial Calcification, Peripheral Arterial Disease
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of…
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT05145478
- Testing
- Shockwave Intravascular Lithotripsy (IVL)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Intravascular Lithotripsy; Rotational Atherectomy; OFDI
Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI
The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal…
- Trial name
- ICARE (NCT05394649)
- Testing
- Intravascular Lithotripsy, Rotational Atherectomy
- Where
- 17 sites in France
- Volunteers
- 178 people
- Sponsor
- University Hospital, Clermont-Ferrand
PCI, Coronary Arterial Disease (CAD)
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing…
- Conditions
- PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
- Trial name
- Shape (NCT07093788)
- Testing
- super high-pressure balloon, intravascular lithotripsy (IVL)
- Where
- 3 sites in China
- Volunteers
- 78 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
In Stent Restenosis, Coronary Artery Calcification
IVL for Stent Underexpantsion
The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers.
- Conditions
- In Stent Restenosis, Coronary Artery Calcification, Intravascular Lithotripsy
- Trial name
- IVL-DRAGON (NCT05112250)
- Testing
- Percutaneous Coronary Intervention
- Where
- 16 sites in Poland
- Volunteers
- 62 people
- Sponsor
- Medical University of Silesia