Clinical trials: Intravascular Lithotripsy
Coronary Arterial Disease, Calcified Coronary Artery Disease
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed.
- Trial name
- IVL (NCT07407738)
- Testing
- Shockwave IVL, Shockfast IVL
- Where
- 13 sites in France, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Shunmei Medical
Peripheral Arterial Disease (PAD)
Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™)…
- Trial name
- POWER PAD 2 (NCT06457685)
- Testing
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Where
- 19 sites in United States
- Volunteers
- 115 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Vascular Calcification
Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions
Study Design Prospective, multicenter, single-blind, randomized controlled trial Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using…
- Trial name
- CRUSH-CALC (NCT07279987)
- Testing
- Super High-Pressure Non-Compliant Balloon, Intravascular Lithotripsy System
- Where
- China
- Volunteers
- 162 people
- Sponsor
- Lin Zhao
Aortic Diseases, Aorto-Iliac Atherosclerosis
Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices…
- Conditions
- Aortic Diseases, Aorto-Iliac Atherosclerosis, Peripheral Arterial Disease
- Trial name
- SHOCK-ACCESS (NCT05880641)
- Where
- 6 sites in Italy
- Volunteers
- 40 people
- Sponsor
- EndoCore Lab s.r.l.
Coronary Arterial Disease (CAD)
FORWARD CAD IDE Study
The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the…
- Trial name
- NCT06662500
- Testing
- Intravascular Lithotripsy
- Where
- 34 sites in United States, United Kingdom
- Volunteers
- 408 people
- Sponsor
- Shockwave Medical, Inc.
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
Cardiovascular Diseases
SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease.
- Trial name
- NCT07259239
- Testing
- Medical device
- Where
- Singapore
- Volunteers
- 40 people
- Sponsor
- National Heart Centre Singapore
Coronary Artery Disease, Myocardial Infarction
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo…
- Trial name
- NCT05966662
- Testing
- IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
- Where
- 18 sites in United States
- Volunteers
- 145 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease
DISRUPT PAD III Observational Study
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component.
- Trial name
- PAD III OS (NCT05881421)
- Where
- 30 sites in United States, Germany and 1 more
- Volunteers
- 1,373 people
- Sponsor
- Shockwave Medical, Inc.
Calcific Coronary Arteriosclerosis
Prospective Registry on Intravascular Lithotripsy
multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.
- Trial name
- BENELUX-IVL (NCT06577038)
- Testing
- PCI with use of IVL
- Where
- 8 sites in Belgium, Greece and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Leiden University Medical Center
Coronary Artery Disease
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in…
- Trial name
- ISAR-WAVE (NCT06369142)
- Testing
- Intravascular lithotripsy (IVL), Standard non-IVL methods
- Where
- 22 sites in Germany
- Volunteers
- 666 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease, Myocardial Infarction
Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions
To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined…
- Trial name
- ROLLING-STONE (NCT05016726)
- Testing
- Intravascular Lithotripsy
- Volunteers
- 400 people
- Sponsor
- SS Annunziata Hospital, Savigliano
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD III Post-Approval Study (PAS)
The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.
- Trial name
- NCT05021757
- Testing
- Shockwave C2 Coronary IVL
- Where
- United States
- Volunteers
- 1,212 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Angioplasty, Restenosis
Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis.
- Conditions
- Coronary Angioplasty, Restenosis, Lithotripsy, Restenosis of Coronary Artery Stent
- Trial name
- OSCAR (NCT07316504)
- Testing
- Intravascular lithotripsy, Balloon
- Where
- 2 sites in France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Clermont-Ferrand
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease, Coronary Calcification
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in…
- Trial name
- NODULE-SHOCK (NCT07000045)
- Testing
- Intravascular lithotripsy, Rotational atherectomy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Annapoorna Kini
Coronary Artery Calcification, Left Main Coronary Artery Disease
Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention
The IVL Left Main study is a prospective non-randomised pilot study to investigate the mechanical and procedural outcomes and safety of distal left main stenting with coronary lithotripsy in addition to standard techniques in…
- Trial name
- NCT04319666
- Testing
- Left main stenting with intravascular lithotripsy
- Where
- 6 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- St George's, University of London
Coronary Artery Calcification, Coronary Artery Disease
Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.
This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.
- Trial name
- NCT07444346
- Testing
- percutaneous coronary intervention
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Intravascular Lithotripsy
Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial.
- Trial name
- NCT06521905
- Testing
- intravascular lithotripsy, high-pressure ballon
- Volunteers
- 222 people
- Sponsor
- China National Center for Cardiovascular Diseases
Coronary Artery Calcification, Calcific Coronary Arteriosclerosis
ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification
The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone…
- Trial name
- CALC-IVL (NCT07340294)
- Testing
- Intensive Preconditioning Group, Routine preconditioning strategy
- Where
- 4 sites in China
- Volunteers
- 1,096 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine