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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06149650




Registration number
NCT06149650
Ethics application status
Date submitted
15/11/2023
Date registered
29/11/2023

Titles & IDs
Public title
Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Scientific title
Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study
Secondary ID [1] 0 0
CALCIO
Universal Trial Number (UTN)
Trial acronym
CALCIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Limb-Threatening Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Shockwave Medical IVL System

Full cohort - Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Wound healing and freedom from amputation
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Wound healing
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Freedom from amputation
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Amputation-free survival
Timepoint [3] 0 0
through study completion, approximately 2 years
Secondary outcome [4] 0 0
Change in Rutherford classification category
Timepoint [4] 0 0
12 and 24 months
Secondary outcome [5] 0 0
Change in foot ischemia
Timepoint [5] 0 0
12 and 24 months
Secondary outcome [6] 0 0
Change in WIfi score
Timepoint [6] 0 0
12 and 24 months
Secondary outcome [7] 0 0
Freedom from clinically-driven target lesion revascularization (CD-TLR)
Timepoint [7] 0 0
12 and 24 months
Secondary outcome [8] 0 0
CD-TLR-free survival
Timepoint [8] 0 0
through study completion, approximately 2 years
Secondary outcome [9] 0 0
Primary patency rate
Timepoint [9] 0 0
12 and 24 months
Secondary outcome [10] 0 0
Assisted primary patency rate
Timepoint [10] 0 0
12 and 24 months
Secondary outcome [11] 0 0
Secondary patency rate
Timepoint [11] 0 0
12 and 24 months
Secondary outcome [12] 0 0
Technical success of IVL
Timepoint [12] 0 0
on the day of the procedure
Secondary outcome [13] 0 0
Overall procedural success
Timepoint [13] 0 0
on the day of the procedure
Secondary outcome [14] 0 0
Frequency and severity of procedural complications and other adverse events
Timepoint [14] 0 0
Within 30 days after the procedure
Secondary outcome [15] 0 0
Patient-reported health-related quality-of-life
Timepoint [15] 0 0
at 6, 12 and 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Siegen
Country [2] 0 0
Germany
State/province [2] 0 0
Tübingen
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Cardiovascular and Interventional Radiological Society of Europe
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Shockwave Medical, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raman Uberoi, Dr
Address 0 0
Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claire Poulet, Dr
Address 0 0
Country 0 0
Phone 0 0
+431904200371
Fax 0 0
Email 0 0
calcio@cirse.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06149650