| Primary | Minimum Stent Area After Percutaneous Coronary Intervention | Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS) | | Posted | | Mean | Standard Deviation | mm^2 | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0006.7± 1.7
- OG0016.9± 1.8
|
|
| |
| Secondary | In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation | In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound | | Posted | | Mean | Standard Deviation | mm^2 | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Minimum Percent Stent Expansion After Percutaneous Coronary Intervention | Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound | | Posted | | Mean | Standard Deviation | minimum percent expansion | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Mean Percent Stent Expansion After Percutaneous Coronary Intervention | Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound | | Posted | | Mean | Standard Deviation | mean percent expansion | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Dissection After Percutaneous Coronary Intervention | Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound. | | Posted | | Count of Participants | | Participants | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention | Number of Participants with Stent malapposition after Percutaneous Coronary Intervention assessed by intravascular ultrasound. Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall. | | Posted | | Count of Participants | | Participants | | Post-Procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA) | Number of Participants with Dissection after Rotational atherectomy and cutting balloon angioplasty /non-compliant balloon angioplasty (CBA/NCBA) assessed by intravascular ultrasound. A dissection or tear in the vessel wall | one participant missing imaging for this outcome measure | Posted | | Count of Participants | | Participants | | Post-CBA/NCBA before stent, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon | Number of Participants with a Calcium fracture after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound. A fracture within the calcified area. | one participant missing imaging for this outcome measure | Posted | | Count of Participants | | Participants | | Post-Procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography | Defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement). | | Posted | | Mean | Standard Deviation | mm | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography | Defined as the minimal luminal diameter in segment after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement). | | Posted | | Mean | Standard Deviation | mm | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Percent Residual Diameter Stenosis In-segment After Stent Implantation | Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography | | Posted | | Mean | Standard Deviation | percent residual diameter stenosis | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Percent Residual Diameter Stenosis In-stent After Stent Implantation | Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography | | Posted | | Mean | Standard Deviation | percent residual diameter stenosis | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Minimum Lumen Diameter In-segment After Stent Implantation | Minimum lumen diameter in-segment after stent implantation assessed by Angiography | | Posted | | Mean | Standard Deviation | mm | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Minimum Lumen Diameter In-stent After Stent Implantation | Minimum lumen diameter in-stent after stent implantation assessed by Angiography | | Posted | | Mean | Standard Deviation | mm | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Dissection Type B or Greater | Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography. | three participants missing imaging for this outcome measure | Posted | | Count of Participants | | Participants | | Post-CBA/NCBA before stent and after stent, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation | Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel | | Posted | | Count of Participants | | Participants | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Side Branch Closure After Stent Implantation | Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch | | Posted | | Count of Participants | | Participants | | Post-procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With a Balloon Rupture | Device problem; Rupture of the cutting balloon or plain old balloon | | Posted | | Count of Participants | | Participants | | Post-Procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Blade Detachment | Device problem; detachment of a blade from the cutting balloon | | Posted | | Count of Participants | | Participants | | Post-Procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Difficulty in Withdrawing/Advancing the Device | Device problem; difficulty in moving the balloon within the vessel during the procedure | | Posted | | Count of Participants | | Participants | | Post-Procedure, Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention | The Society for Cardiovascular Angiography and Intervention (SCAI) defines clinically relevant MI after PCI as an elevation of cardiac biomarkers (CK-MB or troponin) above specified thresholds within 48 hours of the procedure, with or without new Q waves or LBBB on ECG. This definition aims to identify meaningful ischemic injury to the myocardium that is associated with adverse clinical outcomes. | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention | Myocardial infarction is defined as heart muscle damage due to lack of blood flow, based on characteristic symptoms, ECG changes, and cardiac biomarker elevation, especially troponin. Elevated levels of cardiac biomarkers, especially troponin, along with ECG changes and cardiac symptoms, indicate myocardial infarction according to the universal definition. | | Posted | | Number | | percent of participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention | Bleeding Academic Research Consortium (BARC) Type 3
- Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
- Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
- Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 5
- Probable fatal bleeding
- Definite fatal bleeding (overt or autopsy or imaging confirmation)
| | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
|
| Secondary | Number of Participants With Vascular Complications After Percutaneous Coronary Intervention | | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Atherectomy + Cutting Balloon | angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | | OG001 | Rotational Atherectomy + Plain Old Balloon | angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement |
| |
| Secondary | Angina Status According to Canadian Cardiovascular Society (CSS) Classification | The Canadian Cardiovascular Society (CCS) grading scale is a classification system used to grade the severity of angina pectoris based on symptoms and their relationship to physical activity. Grade I: Ordinary physical activity like walking does not cause angina. Angina only occurs with strenuous, rapid, prolonged exertion during recreation or work. Grade II: Slight limitation of ordinary activity. Angina occurs when walking/climbing stairs rapidly, walking uphill, after meals, in cold/wind, under stress, or early morning. Angina occurs when walking more than 2 blocks or climbing more than 1 flight of stairs at a normal pace. Grade III: Marked limitation of ordinary activity. Angina occurs when walking 1-2 blocks or climbing 1 flight of stairs at a normal pace. Grade IV: Inability to carry out any physical activity without angina. Anginal symptoms may be present at rest. Higher grades indicate more limitations to activity due to angina. | | Not Posted | Dec 2024 | | | | | 270 days | | Participants | | | | |