NCT07109479

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

A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device for Pre-treatment of De Novo Calcified Stenotic Coronary Lesion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Spectrumedics Medical Technology(Shanghai)Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 Device for the pre-treatment of calcified, stenotic de novo coronary artery lesions .

Detailed description

The approved IVL devices are based on balloon design, and the biggest limitation is the crossability, especially in the severe stenosis lesions. Coronary Forward IVL Catheter allow the catheter to modify calcium in tight, difficult to cross lesions to increase the compliance of the vessel and allow further crossing of the device or additional treatment. This trial consists of two parts: Part 1 (RCT part): this part is a prospective, multicenter, randomized controlled, study in subjects with moderate-to-severe calcification.180 eligible subjects are planned to enroll . Part 2 (Single-arm part):This part is a single-arm study in subjects with calcified lesions that are Chronic Total Occlusions (CTOs)(with minimum 30 subjects).

Conditions

• Coronary Arterial Disease

Interventions

Type	Name	Description
DEVICE	Intravascular Lithotripsy	study group will receive the investigational devices (Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device) for calcified lesion pre-treatment.
DEVICE	Rotational Atherectomy	control group will receive the control device (Coronary Rotational Atherectomy System)

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-08-07
• Last updated: 2025-08-07

Locations

1 site across 1 country: China