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

Not Applicable

Completed

Conditions: Coronary Artery Disease
Atherosclerosis

Interventions: Procedure: rotational atherectomy
Device: cutting balloon
Device: plain old balloon

Registration Number: NCT04865588

Lead Sponsor: Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Not provided

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rotational atherectomy + plain old balloon	rotational atherectomy	angioplasty with rotational atherectomy followed by plain old balloon
rotational atherectomy + cutting balloon	rotational atherectomy	angioplasty with rotational atherectomy followed by cutting balloon
rotational atherectomy + cutting balloon	cutting balloon	angioplasty with rotational atherectomy followed by cutting balloon
rotational atherectomy + plain old balloon	plain old balloon	angioplasty with rotational atherectomy followed by plain old balloon

Primary Outcome Measures

Name	Time	Method
Minimum Stent Area After Percutaneous Coronary Intervention	Post-procedure, Day 0	Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Dissection After Percutaneous Coronary Intervention	Post-procedure, Day 0	Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.
Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography	Post-procedure, Day 0	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).
Percent Residual Diameter Stenosis In-stent After Stent Implantation	Post-procedure, Day 0	Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography
In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation	Post-procedure, Day 0	In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention	Post-procedure, Day 0	Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound
Mean Percent Stent Expansion After Percutaneous Coronary Intervention	Post-procedure, Day 0	Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound
Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon	Post-Procedure, 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.
Number of Participants With Difficulty in Withdrawing/Advancing the Device	Post-Procedure, Day 0	Device problem; difficulty in moving the balloon within the vessel during the procedure
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention	30 days
Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention	Post-Procedure, 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.
Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)	Post-CBA/NCBA before stent, Day 0	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
Percent Residual Diameter Stenosis In-segment After Stent Implantation	Post-procedure, Day 0	Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography
Minimum Lumen Diameter In-segment After Stent Implantation	Post-procedure, Day 0	Minimum lumen diameter in-segment after stent implantation assessed by Angiography
Number of Participants With Side Branch Closure After Stent Implantation	Post-procedure, Day 0	Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch
Number of Participants With a Balloon Rupture	Post-Procedure, Day 0	Device problem; Rupture of the cutting balloon or plain old balloon
Number of Participants With Blade Detachment	Post-Procedure, Day 0	Device problem; detachment of a blade from the cutting balloon
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention	30 days	Stent Thrombosis
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention	30 days	Vascular complication
Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography	Post-procedure, Day 0	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).
Minimum Lumen Diameter In-stent After Stent Implantation	Post-procedure, Day 0	Minimum lumen diameter in-stent after stent implantation assessed by Angiography
Number of Participants With Dissection Type B or Greater	Post-CBA/NCBA before stent and after stent, Day 0	Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography.
Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation	Post-procedure, Day 0	Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention	30 days	Non-Cardiac Death
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention	30 days	Revascularization
Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention	30 days	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)
Angina Status According to Canadian Cardiovascular Society (CSS) Classification	270 days	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.
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention	30 days	Cardiac Death
Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention	30 days	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.
Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention	30 days	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.
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention	30 days	Revascularization

Trial Locations

Locations (2): Saint Francis Hospital and Heart Center
🇺🇸
Roslyn, New York, United States
The Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States