Clinical trial NCT06149650: Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Official title: Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Limb-Threatening Ischemia
Keywords: CLTI
Lead sponsor: Cardiovascular and Interventional Radiological Society of Europe
Sponsor class: OTHER
Collaborators: name: Shockwave Medical, Inc.
First posted: 2023-11-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.

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.


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.

Primary outcomes:
measure: Wound healing and freedom from amputation
timeFrame: 12 months
Secondary outcomes:
measure: Wound healing
timeFrame: 24 months
measure: Freedom from amputation
timeFrame: 24 months
measure: Amputation-free survival
timeFrame: through study completion, approximately 2 years
measure: Change in Rutherford classification category
timeFrame: 12 and 24 months
measure: Change in foot ischemia
timeFrame: 12 and 24 months
measure: Change in WIfi score
timeFrame: 12 and 24 months
measure: Freedom from clinically-driven target lesion revascularization (CD-TLR)
timeFrame: 12 and 24 months
measure: CD-TLR-free survival
timeFrame: through study completion, approximately 2 years
measure: Primary patency rate
timeFrame: 12 and 24 months
measure: Assisted primary patency rate
timeFrame: 12 and 24 months
measure: Secondary patency rate
timeFrame: 12 and 24 months
measure: Technical success of IVL
timeFrame: on the day of the procedure
measure: Overall procedural success
timeFrame: on the day of the procedure
measure: Frequency and severity of procedural complications and other adverse events
timeFrame: Within 30 days after the procedure
measure: Patient-reported health-related quality-of-life
timeFrame: at 6, 12 and 24 months
Other outcomes:
Locations:
city: Siegen
country: Germany
facility: St Marien-Krankenhaus
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: St George&#39;s University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom
name: Raman Uberoi, Dr
role: STUDY_CHAIR
affiliation: Cantonal Hospital Winterthur, Winterthur, Switzerland
name: Christoph Binkert, Prof. Dr
role: STUDY_CHAIR
affiliation: Municipal Clinic Karlsruhe, Karlsruhe, Germany
name: Peter Reimer, Prof. Dr
role: STUDY_CHAIR
References: