Clinical trial NCT04865588: Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Official title: Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: calcified plaque
angioplasty
cutting balloon
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Minimum Stent Area After Percutaneous Coronary Intervention
timeFrame: Post-procedure, Day 0
Secondary outcomes:
measure: In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation
timeFrame: Post-procedure, Day 0
measure: Minimum Percent Stent Expansion After Percutaneous Coronary Intervention
timeFrame: Post-procedure, Day 0
measure: Mean Percent Stent Expansion After Percutaneous Coronary Intervention
timeFrame: Post-procedure, Day 0
measure: Number of Participants With Dissection After Percutaneous Coronary Intervention
timeFrame: Post-procedure, Day 0
measure: Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention
timeFrame: Post-Procedure, Day 0
measure: Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)
timeFrame: Post-CBA/NCBA before stent, Day 0
measure: Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon
timeFrame: Post-Procedure, Day 0
measure: Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography
timeFrame: Post-procedure, Day 0
measure: Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography
timeFrame: Post-procedure, Day 0
measure: Percent Residual Diameter Stenosis In-segment After Stent Implantation
timeFrame: Post-procedure, Day 0
measure: Percent Residual Diameter Stenosis In-stent After Stent Implantation
timeFrame: Post-procedure, Day 0
measure: Minimum Lumen Diameter In-segment After Stent Implantation
timeFrame: Post-procedure, Day 0
measure: Minimum Lumen Diameter In-stent After Stent Implantation
timeFrame: Post-procedure, Day 0
measure: Number of Participants With Dissection Type B or Greater
timeFrame: Post-CBA/NCBA before stent and after stent, Day 0
measure: Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation
timeFrame: Post-procedure, Day 0
measure: Number of Participants With Side Branch Closure After Stent Implantation
timeFrame: Post-procedure, Day 0
measure: Number of Participants With a Balloon Rupture
timeFrame: Post-Procedure, Day 0
measure: Number of Participants With Blade Detachment
timeFrame: Post-Procedure, Day 0
measure: Number of Participants With Difficulty in Withdrawing/Advancing the Device
timeFrame: Post-Procedure, Day 0
measure: Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Number of Participants With Vascular Complications After Percutaneous Coronary Intervention
timeFrame: 30 days
measure: Angina Status According to Canadian Cardiovascular Society (CSS) Classification
timeFrame: 270 days
Other outcomes:
Locations:
city: New York
country: United States
facility: The Icahn School of Medicine at Mount Sinai
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital and Heart Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Samin K Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: