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

NCT07109479 | Not Yet Recruiting

• 1 other identifier: PC-SWFC-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Coronary Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Rate of Device Success

  immediately after IVL intervention

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

  30-day after the procedure

Secondary Outcomes (10)

• Rate of Technical Success

  immediately after the procedure

• Rate of Angiographic Success

  Peri-procedural

• Rate of Procedural Success

  at discharge/up to 7 days after the procedure

• Incidence of serious angiographic complications

  immediately after the procedure

• Incidence of MACE

  during procedure, at discharge (up to 7 days after the procedure) ,180 days after the procedure

Other Outcomes (2)

• Quantitative Coronary Angiography (QCA) Subgroup

  immediately after the procedure

• Optical Coherence Tomography (OCT) Subgroup

  immediately after the procedure

Study Arms (2)

Intravascular Lithotripsy

EXPERIMENTAL

Device: Intravascular Lithotripsy

Coronary Rotational Atherectomy

ACTIVE COMPARATOR

Device: Rotational Atherectomy

Interventions

Intravascular Lithotripsy DEVICE

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.

Intravascular Lithotripsy

Rotational Atherectomy DEVICE

control group will receive the control device (Coronary Rotational Atherectomy System)

Coronary Rotational Atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age ≥18 years, male or female.
• )Primary coronary artery disease (with evidence of asymptomatic myocardial ischemia, stable/unstable angina, or old MI) scheduled for non-emergent PCI.
• )Pre-procedure Left Ventricular Ejection Fraction (LVEF) ≥30%.
• )Voluntarily participate in this study and sign Informed Consent Form (ICF), willing to comply with study procedures and follow-up.
• 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:
• RCT part: Moderate-to-severe calcification AND stenosis ≥90% and \<100% (length ≤60 mm). (Moderate Calcification: Clearly visible high-density shadows during cardiac motion; Severe Calcification: Clearly visible high-density shadows visible without cardiac motion).
• Single-arm part: Calcified lesion AND Chronic Total Occlusion (CTO) (length ≤20 mm).
• Guidewire positioned in the true lumen distal to the target lesion and not in the subintimal space prior to device use.

You may not qualify if:

• \) Planning use of scoring/cutting balloons, Excimer Laser Coronary Atherectomy (ELCA), or Coronary Intravascular Lithotripsy balloons for calcified lesion modification prior to study device use.
• \) NYHA Class III or IV.
• \) Currently on dialysis or serum creatinine level \>2.5 mg/dL (or 221 µmol/L).
• \) Severe coagulation disorder (platelet count \<100×10⁹/L).
• \) Hyperviscosity diseases (e.g., polycythemia vera, platelet count \>750×10⁹/L).
• \) Cardiac shock with clinical signs or symptoms.
• \) Active systemic infection.
• \) Moderate-to-severe anemia (hemoglobin \<90 g/L).
• \) Acute Myocardial Infarction within 1 month prior to procedure.
• \) Stroke or Transient Ischemic Attack (TIA) within 3 months prior to procedure.
• \) Active gastrointestinal ulcer or bleeding within 3 months prior to procedure.
• \) Expected life expectancy \<12 months as assessed by the investigator.
• \) Known intolerance to antiplatelet or anticoagulant therapy.
• \) Known allergy to study device components or contrast media.
• \) Known pregnancy or lactation (female subjects).

Sponsors & Collaborators

• Spectrumedics Medical Technology(Shanghai)Co.,Ltd: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Central Study Contacts

Fei Yu

CONTACT

15996030368; fei.yu@spectrumedics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

CN (1)