Intravascular Lithotripsy

DEVICE19 trials

Sponsors

University Hospital Ostrava, Assiut University, Medical Care Center Prof. Mathey, Prof. Schofer, Ltd., Shockwave Medical, Inc., SS Annunziata Hospital, Savigliano

Conditions

Acute Coronary Syndrome (ACS)Angioplasty, Transluminal, Percutaneous CoronaryCalcificationChronic Coronary SyndromeCoronary AngioplastyCoronary Arterial DiseaseCoronary Arterial Disease (CAD)Coronary Artery Calcification

Phase 4

Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

Not yet recruitingNCT06736665

Spanish Society of CardiologyAcute Coronary Syndrome (ACS), Chronic Coronary Syndrome, Coronary Arterial Disease (CAD) +6

Start: 2025-03-31End: 2026-12-31Target: 50Updated: 2024-12-17

Unknown Phase

Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

University Hospital OstravaCoronary Artery Calcification

Start: 2020-06-01End: 2023-12-31Target: 40Updated: 2023-09-11

IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

CompletedNCT04556682

Assiut UniversityCoronary Calcification

Start: 2021-05-01End: 2022-02-25Updated: 2022-08-02

Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.Calcification, Coronary Artery Disease

Start: 2022-01-31End: 2024-06-30Target: 100Updated: 2021-08-17

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

Active, not recruitingNCT05007925

Shockwave Medical, Inc.Peripheral Artery Disease

Start: 2021-11-18End: 2026-04-01Updated: 2025-08-05

Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions

SS Annunziata Hospital, SaviglianoCoronary Artery Disease, Myocardial Infarction

Start: 2021-10-01End: 2024-10-30Target: 400Updated: 2021-08-23

Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

University Hospital, Clermont-FerrandIntravascular Lithotripsy; Rotational Atherectomy; OFDI

Start: 2022-08-04End: 2025-05-31Target: 178Updated: 2022-08-10

BOLT Lithotripsy RESTORE BTK Trial

CompletedNCT05535907

Bolt MedicalPeripheral Arterial Disease, Peripheral Vascular Disease

Start: 2022-09-05End: 2024-04-04Updated: 2025-07-25

BOLT Lithotripsy RESTORE ATK Trial

CompletedNCT05662787

Bolt MedicalPeripheral Arterial Disease, Peripheral Vascular Diseases

Start: 2023-01-19End: 2024-07-30Updated: 2025-02-07

FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter

CompletedNCT05858905

Shockwave Medical, Inc.Peripheral Arterial Disease

Start: 2023-06-27End: 2025-04-21Updated: 2025-06-26

Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial

CompletedNCT06089135

Baim Institute for Clinical ResearchTreatment in Calcified Coronary Disease

Start: 2023-12-31End: 2025-09-30Updated: 2026-01-23

Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

RecruitingNCT06112171

University of LeipzigPeripheral Arterial Disease

Start: 2024-02-13End: 2030-12-31Target: 120Updated: 2025-01-23

Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

Active, not recruitingNCT06181240

Bolt MedicalCoronary Artery Calcification, Coronary Artery Disease

Start: 2024-01-19End: 2028-03-20Target: 420Updated: 2026-03-10

Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

RecruitingNCT06238518

Xijing HospitalDe Novo Stenosis, Severely Calcified Coronary Stenoses

Start: 2024-01-05End: 2025-03-01Target: 220Updated: 2024-02-02

Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy

Not yet recruitingNCT06521905

China National Center for Cardiovascular DiseasesIntravascular Lithotripsy

Start: 2024-10-01End: 2026-10-01Target: 222Updated: 2024-07-29

FORWARD CAD IDE Study

RecruitingNCT06662500

Shockwave Medical, Inc.Coronary Arterial Disease (CAD)

Start: 2025-04-04End: 2027-12-01Target: 408Updated: 2026-03-19

Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

RecruitingNCT07000045

Annapoorna KiniCoronary Artery Disease, Coronary Calcification

Start: 2025-10-06End: 2027-12-31Target: 120Updated: 2025-10-09

Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device

Not yet recruitingNCT07109479

Spectrumedics Medical Technology(Shanghai)Co.,LtdCoronary Arterial Disease

Start: 2025-10-01End: 2027-12-31Target: 180Updated: 2025-08-07

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

RecruitingNCT07316504

University Hospital, Clermont-FerrandAngioplasty, Transluminal, Percutaneous Coronary, Coronary Angioplasty, Coronary Artery Disease +10

Start: 2025-10-22End: 2031-09-30Target: 80Updated: 2026-01-05

Related Papers

Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries

JACC: Cardiovascular Interventions2026-01-01

Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS– Coronary Calcification Study)

BMC Cardiovascular Disorders2025-09-02