Chronic Limb-Threatening Ischemia
Conditions
Keywords
CLTI
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.
Interventions
DEVICEShockwave 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.
Sponsors
Cardiovascular and Interventional Radiological Society of Europe
Shockwave Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 24 months | Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) |
| 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). |
| 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 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 |
| 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) |
| Primary patency rate | 12 and 24 months | freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm) |
| 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 |
| 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 |
| Technical success of IVL | on the day of the procedure | residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention |
| Overall procedural success | on the day of the procedure | residual stenosis ≤30% by the end of the complete procedure |
| 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 |
| Patient-reported health-related quality-of-life | at 6, 12 and 24 months | EuroQol questionnaire EQ-5D-5L |
Countries
Austria, Canada, France, Germany, Hungary, Spain, Switzerland, United Kingdom
Contacts
STUDY_CHAIRRaman Uberoi, Dr
Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom
STUDY_CHAIRChristoph Binkert, Prof. Dr
Cantonal Hospital Winterthur, Winterthur, Switzerland
STUDY_CHAIRPeter Reimer, Prof. Dr
Municipal Clinic Karlsruhe, Karlsruhe, Germany
Outcome results
None listed