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New treatment option for Coronary Artery Disease
Official title Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy
ClinicalTrials.gov ID: NCT06369142
What this study is testing
- What it's testing
- The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- age ≥18 years and able to give informed consent
- written informed consent to participate in the clinical trial
- typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
- angiographic evidence of coronary artery disease
- de novo lesion in a native coronary artery
You likely can't join if
- myocardial infarction \<1 week
- thrombus in the target vessel
- life expectancy due to other disease \<1 year
- simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
- pregnancy (current, suspected, planned) or positive pregnancy test
See the full eligibility criteria
- age ≥18 years and able to give informed consent
- written informed consent to participate in the clinical trial
- typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
- angiographic evidence of coronary artery disease
- de novo lesion in a native coronary artery
- target vessel diameter 2.5-4 mm
- severe calcification of the target lesion (angiographic grade 3)
- myocardial infarction \<1 week
- thrombus in the target vessel
- life expectancy due to other disease \<1 year
- simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
- pregnancy (current, suspected, planned) or positive pregnancy test
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Mannheim, Baden-Wurttemberg, Germany
- Singen, Baden-Wurttemberg, Germany
- Ulm, Baden-Wurttemberg, Germany
- Augsburg, Bavaria, Germany
- Dachau, Bavaria, Germany
- Erding, Bavaria, Germany
- Ingolstadt, Bavaria, Germany
- Munich, Bavaria, Germany
- München, Bavaria, Germany
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Landshut, Germany, Germany
- Rotenburg an der Fulda, Hesse, Germany
- Bad Oeynhausen, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Trier, Rhineland-Palatinate, Germany
- Dresden, Saxony, Germany
- Bad Oldesloe, Schleswig-Holstein, Germany
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany; Mannheim, Baden-Wurttemberg, Germany; Singen, Baden-Wurttemberg, Germany; Ulm, Baden-Wurttemberg, Germany; Augsburg, Bavaria, Germany; Dachau, Bavaria, Germany and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.