Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
Conditions
Brief summary
The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions.
Interventions
DEVICERotational Atherectomy
Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent
DEVICECutting/Scoring Balloon
Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent
Sponsors
Segeberger Kliniken GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical inclusion criteria * Age above 18 years and consentable * Angiographically proven coronary artery disease * Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve * Written informed consent 2. Angiographic inclusion criteria * De-novo lesion in a native coronary artery * Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation * Luminal diameter reduction of 50-100% by visual estimation * Severe calcification of the target lesion
Exclusion criteria
1. Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-Stent late lumen loss at 9 months | 9 months | Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography. |
| Strategy Success | Intraprocedural | The primary endpoint will be 'Strategy Success' defined as successful stent delivery and expansion with attainment of \< 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without crossover or stent failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-segment binary restenosis at 9 months | 9 months | In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months |
| Stent thrombosis at 9 months, 1 and 2 years | 9 months, 1 and 2 years | Stent thrombosis at 9 months, 1 and 2 years |
| Target vessel failure (TVF) | 9 months, 1 year, 2 years | Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI; Q- or non-Q-wave) and clinically driven target vessel revascularization (TVR) at 9 months, 1 and 2 years |
| Procedural duration | Intraproedural | — |
| Amount of contrast dye | Intraprocedural | — |
| Peri-procedural MI | within 72 hrs | — |
| In-segment late lumen loss at 9 months | 9 months | In-segment late lumen loss (stent length + 5 mm on either side) at 9 months |
Countries
Germany
Outcome results
None listed