Clinical trials: Intravascular Lithotripsy
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 Arterial Disease
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease.
- Trial name
- STRIKE (NCT06636968)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
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, Calcification
Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery.
- Trial name
- NCT06669195
- Testing
- Intravascular lithotripsy group, high-pressure balloon group
- Volunteers
- 40 people
- Sponsor
- Xuzhou Third People's Hospital
Chronic Coronary Insufficiency, Coronary Artery Disease
Microcirculatory Status After Intravascular Lithotripsy
Due to differences in the mechanism of action, intravascular lithotripsy is likely to cause less distal embolization and microcirculatory dysfunction during plaque preparation.
- Trial name
- MARVEL (NCT05134051)
- Testing
- Shockwave® Intravascular Lithotripsy System (Shockwave Medical Inc)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Cardiac Research Institute BV
Calcified Lesions in Small Coronary Vessels
Shockwave IVL + DCB
Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in…
- Trial name
- NCT05625997
- Where
- 2 sites in Brazil, Italy
- Volunteers
- 50 people
- Sponsor
- Rede Optimus Hospitalar SA
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.
Peripheral Artery Disease (PAD), Chronic Limb Threatening Ischemia
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level.
- Trial name
- SHIELD (NCT06713850)
- Testing
- Shockwave balloons
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
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.
Coronary Disease, Coronary Artery Disease
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization.
- Conditions
- Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis
- Trial name
- VICTORY (NCT05346068)
- Testing
- OPN™ NCB Super High Pressure PCI Balloon, Shockwave™ C2 IVL Catheter
- Where
- Switzerland
- Volunteers
- 280 people
- Sponsor
- Luzerner Kantonsspital