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A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational atherectomy + Cutting Balloon | Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational atherectomy in combination with cutting balloon | Procedure | Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint: Numerical in-stent acute lumen gain in mm | The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD. | At the end of the index procedure |
| Co-primary OCT endpoint: Ratio of stent expansion index (SEI) | The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure | At the end of the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical in-stent late lumen loss at 9 month follow-up angiography in mm | In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint. | 9 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of OCT-measured stent excentricity index | Defined as the ratio of minimal lumen diameter and the maximal lumen diameter per cross section at the end of index procedure | Intra-procedural |
Inclusion Criteria:
Clinical inclusion criteria
Angiographic inclusion criteria
Exclusion Criteria:
Clinical exclusion criteria
Angiographic exclusion criteria
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Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Gert Richardt, Prof. | Herzzentrum Segeberger Kliniken GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017225 | Atherectomy, Coronary |
| ID | Term |
|---|---|
| D017073 | Atherectomy |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
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| Rate of angiographic success in percent |
'Angiographic 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. |
| Peri-procedural |
| Rate of strategy success in percent | '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 stent failure. | Peri-procedural |
| Rate of target vessel failure in percent | Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years. | 9 months, 1 and 2 years follow-up |
| Rate of in-segment binary restenosis at 9 months in percent | In-segment binary restenosis at 9 months | 9 months follow-up |
| Rate of stent thrombosis in percent | Stent thrombosis | 9 months, 1 and 2 years follow-up and final 5 years follow-up |
| Rate of peri-procedural myocardial infarction in percent | Peri-procedural myocardial infarction | Peri-procedural |
| Rate of vessel perforation in percent | Rate of vessel perforation | Peri-procedural |
| Numerical procedural duration in min | Procedural duration | Peri-procedural |
| Numerical contrast dye amount in ml | Procedural contrast dye amount | Peri-procedural |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009204 |
| Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |