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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| SIS Medical AG | INDUSTRY |
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The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.
Detailed information is provided elsewhere.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super high-pressure balloon (OPN NC) | Experimental | Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC). |
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| Intravascular lithotripsy (IVL) | Experimental | Patients will be treated with intravascular lithotripsy (IVL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super High Pressure Balloon (OPN NC) | Device | Strategy of super high-pressure balloon angioplasty after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with OPN balloon. Optional additional pre-dilatation with OPN/standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with OPN balloon or standard NC balloon is permitted at the operator´s discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Final angiographic minimal lumen diameter | The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory. | Intraprocedural. |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic Success | Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. | Intraprocedural. |
| Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Rheude, MD | Contact | +49 89 1218 2985 | rheude@dhm.mhn.de |
| Name | Affiliation | Role |
|---|---|---|
| Salvatore Cassese, MD, PhD | Deutsches Herzzentrum Munich | Principal Investigator |
| Tobias Rheude, MD | Deutsches Herzzentrum Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum | Recruiting | Bad Oeynhausen | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36609101 | Derived | Scalamogna M, Abdel-Wahab M, Mashayekhi K, Fusaro M, Leistner DM, Ayoub M, Xhepa E, Joner M, Kastrati A, Cassese S, Rheude T. Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial. Cardiovasc Revasc Med. 2023 Apr;49:22-27. doi: 10.1016/j.carrev.2022.12.008. Epub 2022 Dec 30. |
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| Intravascular lithotripsy (IVL) | Device | Strategy of IVL after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with IVL balloon. Optional additional pre-dilatation with standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with standard NC balloon is permitted at the operator´s discretion. |
|
Defined as angiographic success without the occurrence of major adverse cardiac event (MACE), a composite of cardiac death, target-vessel related MI and repeat target-vessel revascularization, during index hospitalization.
| During index hospitalization, assessed up to 30 days. |
| Strategy Success | Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy | Intraprocedural. |
| Acute lumen gain | Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD. | Intraprocedural. |
| Complementary lesion preparation | Need for complementary lesion preparation with rotational atherectomy | Intraprocedural. |
| MACE rates | Occurrence of major adverse cardiac event (MACE) up to 30 days. | 30 days. |
| Stent expansion as assessed by OCT imaging. | Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging. | Intraprocedural. |
| Cost-effectiveness analysis | Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation. | Intraprocedural. |
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt am Main | Germany |
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| MEDICLIN Herzzentrum Lahr | Recruiting | Lahr | 77933 | Germany |
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| Deutsches Herzzentrum Muenchen | Recruiting | München | Germany |
|