Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study

Recruiting

• Conditions: Chronic Limb-Threatening Ischemia
• Interventions: Device: Shockwave Medical IVL System

• Registration Number: NCT06149650
• Lead Sponsor: Cardiovascular and Interventional Radiological Society of Europe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Study Start: 2024-07-15
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2028-07-15
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full cohort	Shockwave Medical IVL System	Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care

Primary Outcome Measures

Name	Time	Method
Wound healing and freedom from amputation	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 Outcome Measures

Name	Time	Method
Change in Rutherford classification category	12 and 24 months	Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)
Change in foot ischemia	12 and 24 months	Change in ankle-brachial index or toe pressure, depending on which data is available
Amputation-free survival	through study completion, approximately 2 years	time between IVL treatment and amputation of the target limb, minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure)
Change in WIfi score	12 and 24 months	Three-digit score for comprehensive assessment of wound, ischemia and foot infection
Freedom from clinically-driven target lesion revascularization (CD-TLR)	12 and 24 months	freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.
CD-TLR-free survival	through study completion, approximately 2 years	time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm)
Wound healing	24 months	Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)
Overall procedural success	on the day of the procedure	residual stenosis ≤30% by the end of the complete procedure
Secondary patency rate	12 and 24 months	freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion
Frequency and severity of procedural complications and other adverse events	Within 30 days after the procedure	Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe (PMID: 28584945)
Freedom from amputation	24 months	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).
Primary patency rate	12 and 24 months	freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm)
Technical success of IVL	on the day of the procedure	residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention
Patient-reported health-related quality-of-life	at 6, 12 and 24 months	EuroQol questionnaire EQ-5D-5L
Assisted primary patency rate	12 and 24 months	freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion

Trial Locations

Locations (5)

St Marien-Krankenhaus; 🇩🇪 Siegen, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Royal Free London NHS Foundation Trust; 🇬🇧 London, United Kingdom

St George&#39;s University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom