RECRUITINGOBSERVATIONAL

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - \< 18 years old; - Incapacity or refusal to give willing to sign a consent form; - Ongoing pregnancy; - Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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 (20)

Krankenhaus der Barmherzigen Brüder

Eisenstadt, Austria

Medizinische Universität Graz

Graz, Austria

Krankenhaus Barmherzige Brüder Linz

Linz, Austria

Klinik Hietzing

Vienna, Austria

Klinik Florisdorf

Vienna, Austria

Hôpital Sacré Coeur de Montréal

Montreal, Canada

CHU François Mitterrand

Dijon, France

Institute Mutualiste Montsouris

Paris, France

Rhéna Clinique de Strasbourg

Strasbourg, France

Universitätsklinikum Köln

Cologne, Germany

Universitätsmedizin Essen

Essen, Germany

KRH Klinikum Robert Koch Gehrden

Hanover, Germany

SLK-Heilbronn

Heilbronn, Germany

Städtisches Klinikum

Karlsruhe, Germany

Evangelisches Krankenhaus

Mülheim, Germany

Friedrich Ebert Krankenhaus

Neumünster, Germany

Schön Klinik Rendsburg

Rendsburg, Germany

St Marien-Krankenhaus

Siegen, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Semmelweis University

Budapest, Hungary