Not Yet RecruitingNot Applicable

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

China180 participantsStarted 2025-10-01

Plain-language 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 .

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Target lesion is de novo calcified stenotic coronary lesion with no prior intervention.
✓. Target lesion reference vessel diameter is 2.5-4.0 mm.
✓. Target lesion meets ONE of the following:
✓. Guidewire positioned in the true lumen distal to the target lesion and not in the subintimal space prior to device use.

Exclusion criteria

✕. Unprotected left main coronary artery disease (stenosis \>50%).
✕. Serious angiographic complication in the target vessel prior to study device use.
✕. Presence of thrombus or suspected thrombus in the target vessel.
✕. Aneurysm within 10 mm of the target lesion in the target vessel.
✕. Presence of other lesions with stenosis \>50% within the target vessel.
✕. CTO lesion with excessive tortuosity (\>45°) or length \>20 mm.
✕. Stent implanted within 5 mm proximal or distal to the target lesion.
✕. Target lesion accessible only via saphenous vein graft (SVG) or arterial graft.

What they're measuring

Rate of Device Success

Timeframe: immediately after IVL intervention

Freedom from Major Adverse Cardiovascular Events (MACE) within 30 days post-procedure

Timeframe: 30-day after the procedure

Trial details

NCT IDNCT07109479

SponsorSpectrumedics Medical Technology(Shanghai)Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Fei Yu

15996030368 fei.yu@spectrumedics.com

View on ClinicalTrials.gov More Coronary Arterial Disease trials