Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Chronic Limb-Threatening Ischemia Clinical Trial

— CALCIO  

Official title:

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06149650
• Other study ID #: CALCIO
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: April 2028

Study information

• Verified date: November 2023
• Source: Cardiovascular and Interventional Radiological Society of Europe
• Contact: Claire Poulet, Dr
• Phone: +43 1904 2003 71
• Email: calcio[@]cirse.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Ischemia

Intervention

Device:
• Shockwave Medical IVL System
Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular and Interventional Radiological Society of Europe	Shockwave Medical, Inc.

Outcome

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