Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions

Conditions
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Coronary Artery Disease, Atherosclerosis

Intervention / Treatment
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* Procedure: rotational atherectomy
* Device: cutting balloon
* Device: plain old balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Adults Patients ≥18 years of age Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography Patients eligible for percutaneous coronary intervention Exclusion Criteria Patients in cardiogenic shock Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months Currently participating in another investigational drug or device study Patients referred to coronary artery bypass grafting after heart team discussion Angiographic Specific Exclusion Criteria: Lesion(s) with angulation > 45 degrees by visual estimate Lesion(s) stenosis through which a guidewire will not pass. Last remaining vessel with compromised (<30%) left ventricular function Saphenous vein grafts Angiographic evidence of thrombus Angiographic evidence of significant dissection at the treatment site Lesion(s) with previously placed stent within 10 mm (visual estimate)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rotational atherectomy + cutting balloon<br>angioplasty with rotational atherectomy followed by cutting balloon | Procedure: rotational atherectomy<br>* angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification<br>Device: cutting balloon<br>* a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs<br>|
| Active Comparator: rotational atherectomy + plain old balloon<br>angioplasty with rotational atherectomy followed by plain old balloon | Procedure: rotational atherectomy<br>* angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification<br>Device: plain old balloon<br>* current standard treatment of stent placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum Stent Area after Percutaneous Coronary Intervention assessed by intravascular ultrasound | mm^2 | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Minimum lumen area after stent implantation assessed by intravascular ultrasound | mm^2 | Day 0 | 
| In-segment Minimum lumen area assessed post-dilatation by intravascular ultrasound | mm^2 | Day 0 | 
| Minimum stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound | mm^2 | Day 0 | 
| Mean stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound | In % | Day 0 | 
| Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound | A dissection or tear in the vessel wall | Day 0 | 
| 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. | Day 0 | 
| Number of Participants with Dissection after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound | A dissection or tear in the vessel wall | Day 0 | 
| 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 | Day 0 | 
| Acute lumen gain in stent 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). | Day 0 | 
| Acute lumen gain in segment 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). | Day 0 | 
| Residual diameter stenosis in-segment after stent implantation assessed by Angiography | In % | Day 0 | 
| Residual diameter stenosis in-stent after stent implantation assessed by Angiography | In % | Day 0 | 
| Minimum lumen diameter in-segment after stent implantation assessed by Angiography | mm | Day 0 | 
| Minimum lumen diameter in-stent after stent implantation assessed by Angiography | mm | Day 0 | 
| Number of Participants with Dissection Type B or greater after stent implantation assessed by Angiography | A dissection or tear in the vessel wall | Day 0 | 
| Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography | Perforation of a vessel | Day 0 | 
| Number of Participants with side branch closure after stent implantation assessed by Angiography | Occlusion of a side branch | Day 0 | 
| Number of Participants with a balloon rupture | Device problem; Rupture of the cutting balloon or plain old balloon | Day 0 | 
| Number of Participants with blade detachment | Device problem; detachment of a blade from the cutting balloon | 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 | Day 0 | 
| Number of Participants who died of all-causes (cardiac and non-cardiac) after Percutaneous Coronary Intervention |  | up to 270 days | 
| Number of Participants who died of cardiac death after Percutaneous Coronary Intervention | Cardiac Death | up to 270 days | 
| Number of Participants who died of non-Cardiac death after Percutaneous Coronary Intervention | Non-Cardiac Death | up to 270 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. | up to 270 days | 
| Number 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. | up to 270 days | 
| Number of Participants with Target lesion revascularization after Percutaneous Coronary Intervention | Revascularization | up to 270 days | 
| Number of Participants with Target vessel revascularization after Percutaneous Coronary Intervention | Revascularization | up to 270 days | 
| Number of Participants with Stent thrombosis (definite/probable) after Percutaneous Coronary Intervention | Stent Thrombosis | up to 270 days | 
| Number of Participants with Major bleeding (BARC 3 or 5) after Percutaneous Coronary Intervention | Bleeding | up to 270 days | 
| Number of Participants with Vascular complications after Percutaneous Coronary Intervention | Vascular complication | up to 270 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. | up to 270 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcified plaque, angioplasty, cutting balloon