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

Coronary Artery Disease Clinical Trial

— ROTA-CUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865588
• Other study ID #: GCO 21-0532
• Status: Completed
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: December 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 12, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease

Intervention

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
• plain old balloon
current standard treatment of stent placement

Locations

Country	Name	City	State
United States	The Icahn School of Medicine at Mount Sinai	New York	New York
United States	Saint Francis Hospital and Heart Center	Roslyn	New York

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

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