Coronary Arterial Disease
Conditions
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 .
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).
Interventions
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.
DEVICERotational Atherectomy
control group will receive the control device (Coronary Rotational Atherectomy System)
Sponsors
Spectrumedics Medical Technology(Shanghai)Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * 1\) Age ≥18 years, male or female. 2)Primary coronary artery disease (with evidence of asymptomatic myocardial ischemia, stable/unstable angina, or old MI) scheduled for non-emergent PCI. 3)Pre-procedure Left Ventricular Ejection Fraction (LVEF) ≥30%. 4)Voluntarily participate in this study and sign Informed Consent Form (ICF), willing to comply with study procedures and follow-up. Angiographic Inclusion Criteria: 1. Target lesion is de novo calcified stenotic coronary lesion with no prior intervention. 2. Target lesion reference vessel diameter is 2.5-4.0 mm. 3. 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). 4. Guidewire positioned in the true lumen distal to the target lesion and not in the subintimal space prior to device use.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from Major Adverse Cardiovascular Events (MACE) within 30 days post-procedure | 30-day after the procedure |
| Rate of Device Success | immediately after IVL intervention |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of Patient-Oriented Cardiovascular Endpoint | during procedure, at discharge (up to 7 days after the procedure), 30 days after the procedure, 180 days after the procedure |
| Incidence of Device Deficiencies | immediately after the prcedure |
| Excellent rate of device performance evaluation | Immediately after the procedure |
| Incidence of Adverse Events and Serious Adverse Events | through study completion, 180 days after the procedure |
| Incidence of Target Lesion Failure | during procedure, at discharge (up to 7 days after the procedure), 30 days after the procedure, 180 days after the procedure |
| Rate of Technical Success | immediately after the procedure |
Other
| Measure | Time frame |
|---|---|
| Quantitative Coronary Angiography (QCA) Subgroup | immediately after the procedure |
| Optical Coherence Tomography (OCT) Subgroup | immediately after the procedure |
Countries
China
Contacts
Primary ContactFei Yu
Outcome results
None listed