Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a 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 - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational atherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio. The clinical investigation will be conducted at 2 centers in the US. Up to 48 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
current standard treatment of stent placement
The Icahn School of Medicine at Mount Sinai
New York, New York, United States
Saint Francis Hospital and Heart Center
Roslyn, New York, United States
Minimum Stent Area After Percutaneous Coronary Intervention
Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)
Time frame: Post-procedure, Day 0
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
Time frame: Post-procedure, Day 0
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention
Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound
Time frame: Post-procedure, Day 0
Mean Percent Stent Expansion After Percutaneous Coronary Intervention
Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound
Time frame: Post-procedure, Day 0
Number of Participants With Dissection After Percutaneous Coronary Intervention
Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.
Time frame: Post-procedure, Day 0
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.
Time frame: Post-Procedure, Day 0
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
Time frame: Post-CBA/NCBA before stent, Day 0
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.
Time frame: Post-Procedure, Day 0
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).
Time frame: Post-procedure, Day 0
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).
Time frame: Post-procedure, Day 0
Percent Residual Diameter Stenosis In-segment After Stent Implantation
Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
Percent Residual Diameter Stenosis In-stent After Stent Implantation
Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
Minimum Lumen Diameter In-segment After Stent Implantation
Minimum lumen diameter in-segment after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
Minimum Lumen Diameter In-stent After Stent Implantation
Minimum lumen diameter in-stent after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
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.
Time frame: Post-CBA/NCBA before stent and after stent, Day 0
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
Time frame: Post-procedure, Day 0
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
Time frame: Post-procedure, Day 0
Number of Participants With a Balloon Rupture
Device problem; Rupture of the cutting balloon or plain old balloon
Time frame: Post-Procedure, Day 0
Number of Participants With Blade Detachment
Device problem; detachment of a blade from the cutting balloon
Time frame: Post-Procedure, Day 0
Number of Participants With Difficulty in Withdrawing/Advancing the Device
Device problem; difficulty in moving the balloon within the vessel during the procedure
Time frame: Post-Procedure, Day 0
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention
Time frame: 30 days
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention
Cardiac Death
Time frame: 30 days
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention
Non-Cardiac Death
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention
Revascularization
Time frame: 30 days
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention
Revascularization
Time frame: 30 days
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention
Stent Thrombosis
Time frame: 30 days
Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention
Bleeding Academic Research Consortium (BARC) Type 3 1. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding 2. 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 3. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 5 1. Probable fatal bleeding 2. Definite fatal bleeding (overt or autopsy or imaging confirmation)
Time frame: 30 days
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention
Vascular complication
Time frame: 30 days
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.
Time frame: 270 days
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