Using ShockWAVE technology to treat severely calcified coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of intravascular lithotripsy (IVL) compared to traditional methods for preparing severely calcified coronary lesions before stenting. The study focuses on patients with significant coronary artery disease who have not responded adequately to optimal drug therapy. Participants will undergo procedures to assess the effectiveness of IVL in improving outcomes related to coronary interventions. The trial aims to provide insights into the economic benefits of using IVL in clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. age ≥18 years and able to give informed consent
2. written informed consent to participate in the clinical trial
3. typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
4. angiographic evidence of coronary artery disease
5. de novo lesion in a native coronary artery
6. target vessel diameter 2.5-4 mm
7. severe calcification of the target lesion (angiographic grade 3)

Exclusion Criteria:

1. myocardial infarction \<1 week
2. thrombus in the target vessel
3. life expectancy due to other disease \<1 year
4. simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
5. pregnancy (current, suspected, planned) or positive pregnancy test

Where it's running

• Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin
  Mannheim, Baden-Wurttemberg, Germany Recruiting
• Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische Intensivmedizin)
  Singen, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Ulm
  Ulm, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Augsburg A.ö.R.
  Augsburg, Bavaria, Germany Recruiting
• Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie
  Dachau, Bavaria, Germany Recruiting
• Klinikum Landkreis Erding
  Erding, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Salvatore Cassese, MD, PHD
• Email: cassese@dhm.mhn.de
• Phone: +49891218

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

• Predicting vasopressor needs after anesthesia in elective on-pump CABG using dynamic arterial elastance

  This study tests whether EaDyn measured after induction can help predict which patients will need vasopressors during elective on-pump CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871201

• Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in CABG Patients

  This study tests whether the amount a patient’s pulse pressure varies during surgery relates to how quickly lactate levels drop after CABG.

  Recruiting University of Gaziantep · Gaziantep · NCT07871188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.