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| Name | Class |
|---|---|
| Shockwave Medical, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full cohort | Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Medical IVL System | Device | Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) | 24 months |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Poulet, PhD | Contact | +41 79 385 16 78 | calcio@cirse.org | |
| Dhwani S. Korde, PhD | Contact | +4367762942469 | calcio@cirse.org |
| Name | Affiliation | Role |
|---|---|---|
| Raman Uberoi, Dr | Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom | Study Chair |
| Christoph Binkert, Prof. Dr | Cantonal Hospital Winterthur, Winterthur, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Barmherzigen Brüder | Recruiting | Eisenstadt | 7000 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28584945 | Background | Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5. | |
| 41703104 | Result |
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| 24 months |
| 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 |
| Change in Rutherford classification category | Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss) | 12 and 24 months |
| Change in foot ischemia | Change in ankle-brachial index or toe pressure, depending on which data is available | 12 and 24 months |
| Change in WIfi score | Three-digit score for comprehensive assessment of wound, ischemia and foot infection | 12 and 24 months |
| 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 |
| 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 |
| Primary patency rate | freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm) | 12 and 24 months |
| 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 patency rate | freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion | 12 and 24 months |
| Technical success of IVL | residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention | on the day of the procedure |
| Overall procedural success | residual stenosis ≤30% by the end of the complete procedure | on the day of the procedure |
| 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 | Within 30 days after the procedure |
| Patient-reported health-related quality-of-life | EuroQol questionnaire EQ-5D-5L | at 6, 12 and 24 months |
| Peter Reimer, Prof. Dr | Municipal Clinic Karlsruhe, Karlsruhe, Germany | Study Chair |
| Medizinische Universität Graz | Recruiting | Graz | 8036 | Austria |
|
| Krankenhaus Barmherzige Brüder Linz | Recruiting | Linz | 4020 | Austria |
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| Klinik Hietzing | Recruiting | Vienna | 1130 | Austria |
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| Klinik Florisdorf | Recruiting | Vienna | 1210 | Austria |
|
| Hôpital Sacré Coeur de Montréal | Recruiting | Montreal | H4J 1C5 | Canada |
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| CHU François Mitterrand | Recruiting | Dijon | 21000 | France |
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| Institute Mutualiste Montsouris | Recruiting | Paris | 75014 | France |
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| Rhéna Clinique de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| Universitätsklinikum Köln | Recruiting | Cologne | 50937 | Germany |
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| Universitätsmedizin Essen | Recruiting | Essen | 45147 | Germany |
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| KRH Klinikum Robert Koch Gehrden | Recruiting | Hanover | 30989 | Germany |
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| SLK-Heilbronn | Recruiting | Heilbronn | 74078 | Germany |
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| Städtisches Klinikum | Recruiting | Karlsruhe | 76133 | Germany |
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| Evangelisches Krankenhaus | Recruiting | Mülheim | 45468 | Germany |
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| Friedrich Ebert Krankenhaus | Recruiting | Neumünster | 24534 | Germany |
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| Schön Klinik Rendsburg | Recruiting | Rendsburg | 24768 | Germany |
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| St Marien-Krankenhaus | Recruiting | Siegen | 57072 | Germany |
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| Universitätsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
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| Semmelweis University | Recruiting | Budapest | 1085 | Hungary |
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| Hospital General Universitario Dr. Balmis | Recruiting | Alicante | 03010 | Spain |
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| Hospital General de Granollers | Recruiting | Granollers | 08402 | Spain |
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| University of Navarra | Recruiting | Pamplona | 31006 | Spain |
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| Ente Ospedaliero Cantonale | Recruiting | Lugano | 6500 | Switzerland |
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| Kantonsspital Winterthur | Recruiting | Winterthur | 8400 | Switzerland |
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| Bedfordshire Hospitals NHS Foundation Trust | Recruiting | Bedford | MK42 9DJ | United Kingdom |
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| Frimley Health NHS Foundation Trust | Recruiting | Frimley | GU16 7UJ | United Kingdom |
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| Hull University Teaching Hospitals NHS Trust | Recruiting | Hull | HU3 2JZ | United Kingdom |
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| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | LS1 3EX | United Kingdom |
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| Liverpool University Hospitals NHS Foundation Trust | Recruiting | Liverpool | L7 8XP | United Kingdom |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | NW1 2PG | United Kingdom |
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| Royal Free London NHS Foundation Trust | Recruiting | London | NW3 2QG | United Kingdom |
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| St George's University Hospitals NHS Foundation Trust | Recruiting | London | SW17 0QT | United Kingdom |
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| Imperial College Healthcare NHS Trust | Recruiting | London | W2 1NY | United Kingdom |
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| Manchester University NHS Foundation Trust | Recruiting | Manchester | M13 9WL | United Kingdom |
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| Newcastle upon Tyne Hospitals NHS Foundation Trust | Recruiting | Newcastle | NE1 4LP | United Kingdom |
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| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | OX3 9DU | United Kingdom |
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| University Hospitals Plymouth NHS Trust | Recruiting | Plymouth | PL6 8DH | United Kingdom |
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| Sheffield Teaching Hospitals NHS FT | Recruiting | Sheffield | S10 2JF | United Kingdom |
|
| Uberoi R, Reimer P, Chun JY, Goyault G, Kashef E, Loffroy R, Rand T, Ruffino MA, von Stempel C, Lange T, Zeka B, Poulet C, Kaufmann N, Binkert C. Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a Prospective Multicenter Observational Investigation. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1219-1226. doi: 10.1007/s00270-025-04335-w. Epub 2026 Feb 17. |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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