Clinical trials: Intravascular Lithotripsy
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 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 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
Peripheral Artery Disease (PAD)
IV-X Medical 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 (NCT07746362)
- Testing
- IV-X Medical IVL System
- Volunteers
- 140 people
- Sponsor
- IVX Medical
Peripheral Artery Disease
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.
- Trial name
- NCT05007925
- Testing
- Intravascular Lithotripsy
- Where
- 43 sites in United States, Germany
- Volunteers
- 250 people
- Sponsor
- Shockwave Medical, Inc.
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, Myocardial Infarction
Disrupt CAD III With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic…
- Trial name
- NCT03595176
- Testing
- Lithotripsy
- Where
- 48 sites in United States, France and 2 more
- Volunteers
- 431 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Arterial Disease
Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device
The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy…
- Trial name
- FORWARD IVL (NCT07109479)
- Testing
- Intravascular Lithotripsy, Rotational Atherectomy
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
Peripheral Arterial Disease
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment…
- Trial name
- FORWARD PAD (NCT05858905)
- Testing
- Intravascular Lithotripsy
- Where
- 21 sites in United States
- Volunteers
- 75 people
- Sponsor
- Shockwave Medical, Inc.