Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Limb-Threatening Ischemia
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Enrollment
- 400
- Locations
- 39
- Primary Endpoint
- Wound healing and freedom from amputation
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)
- •Femoropopliteal and/or crural calcified lesions visible on fluoroscopy;
- •Treatment with IVl using the Shockwave Medical IVL System.
Exclusion Criteria
- •\< 18 years old;
- •Incapacity or refusal to give informed consent;
- •Ongoing pregnancy;
- •Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.
Outcomes
Primary Outcomes
Wound healing and freedom from amputation
Time Frame: 12 months
Composite of wound healing defined as the healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) and freedom from amputation defined as the absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).
Secondary Outcomes
- Wound healing(24 months)
- Freedom from amputation(24 months)
- Amputation-free survival(through study completion, approximately 2 years)
- Change in Rutherford classification category(12 and 24 months)
- Change in foot ischemia(12 and 24 months)
- Change in WIfi score(12 and 24 months)
- Freedom from clinically-driven target lesion revascularization (CD-TLR)(12 and 24 months)
- CD-TLR-free survival(through study completion, approximately 2 years)
- Primary patency rate(12 and 24 months)
- Assisted primary patency rate(12 and 24 months)
- Secondary patency rate(12 and 24 months)
- Technical success of IVL(on the day of the procedure)
- Overall procedural success(on the day of the procedure)
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the procedure)
- Patient-reported health-related quality-of-life(at 6, 12 and 24 months)