Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Deutsches Herzzentrum Muenchen666 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

666

Conditions

Coronary Artery Disease

Interventions

Intravascular lithotripsy (IVL)DEVICE

Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm

Standard non-IVL methodsDEVICE

Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Outcomes

Primary Outcomes

Combined endpoint of major cardiac and cerebrovascular events

all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel