Calcified Coronary Artery Disease
Conditions
Brief summary
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 description
Detailed information is provided elsewhere.
Interventions
DEVICESuper High Pressure Balloon (OPN NC)
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.
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.
Sponsors
Deutsches Herzzentrum Muenchen
Abbott Medical Devices
SIS Medical AG
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
* Age above 18 years and able to give consent * Persistent angina despite medical therapy and/or evidence of inducible ischemia * De-novo lesion in a native coronary artery * Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation * Severe calcification of the target lesion as determined by visual estimation at coronary angiography * Unsuccessful lesion preparation with standard non-compliant balloon (\< 30% reduction of baseline diameter stenosis at maximal pressure) * Written informed consent.
Exclusion criteria
* Target lesion is located in a coronary artery bypass graft * Target lesion is an in-stent restenosis * Target lesion is a chronic total occlusion * Target vessel thrombus * Limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final angiographic minimal lumen diameter | Intraprocedural. | The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Success | Intraprocedural. | Defined as target lesion residual angiographic stenosis \< 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. |
| Procedural Success | During index hospitalization, assessed up to 30 days. | 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. |
| Strategy Success | Intraprocedural. | Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy |
| Acute lumen gain | Intraprocedural. | Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD. |
| Complementary lesion preparation | Intraprocedural. | Need for complementary lesion preparation with rotational atherectomy |
| MACE rates | 30 days. | Occurrence of major adverse cardiac event (MACE) up to 30 days. |
| Stent expansion as assessed by OCT imaging. | Intraprocedural. | Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging. |
| Cost-effectiveness analysis | Intraprocedural. | Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORSalvatore Cassese, MD, PhD
Deutsches Herzzentrum Munich
PRINCIPAL_INVESTIGATORTobias Rheude, MD
Deutsches Herzzentrum Munich
Outcome results
None listed