Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions (ROTA-CUT)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Atherosclerosis
• Intervention / Treatment: Procedure: rotational atherectomy; Device: cutting balloon; Device: plain old balloon

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • The Icahn School of Medicine at Mount Sinai
    • Roslyn, New York, United States, 11576
      • Saint Francis Hospital and Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rotational atherectomy + cutting balloon; angioplasty with rotational atherectomy followed by cutting balloon	Procedure: rotational atherectomy; angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification; Device: 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
Active Comparator: rotational atherectomy + plain old balloon; angioplasty with rotational atherectomy followed by plain old balloon	Procedure: rotational atherectomy; angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification; Device: plain old balloon; current standard treatment of stent placement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Post-procedure, Day 0
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention	Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound	Post-procedure, Day 0
Mean Percent Stent Expansion After Percutaneous Coronary Intervention	Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound	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.	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.	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	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.	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).	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).	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	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	Post-procedure, Day 0
Minimum Lumen Diameter In-segment After Stent Implantation	Minimum lumen diameter in-segment after stent implantation assessed by Angiography	Post-procedure, Day 0
Minimum Lumen Diameter In-stent After Stent Implantation	Minimum lumen diameter in-stent after stent implantation assessed by Angiography	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.	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	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	Post-procedure, Day 0
Number of Participants With a Balloon Rupture	Device problem; Rupture of the cutting balloon or plain old balloon	Post-Procedure, Day 0
Number of Participants With Blade Detachment	Device problem; detachment of a blade from the cutting balloon	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	Post-Procedure, Day 0
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention		30 days
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention	Cardiac Death	30 days
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention	Non-Cardiac Death	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.	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.	30 days
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention	Revascularization	30 days
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention	Revascularization	30 days
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention	Stent Thrombosis	30 days
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)	30 days
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention	Vascular complication	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.	270 days

Collaborators and Investigators

• Sponsor: Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
• Investigators: Principal Investigator: Samin K Sharma, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: angioplasty; cutting balloon; calcified plaque
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Atherosclerosis
• Other Study ID Numbers: GCO 21-0532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes