search
Back to results

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

Primary Purpose

Coronary Artery Disease, Atherosclerosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rotational atherectomy
cutting balloon
plain old balloon
Sponsored by
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring calcified plaque, angioplasty, cutting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Icahn School of Medicine at Mount Sinai
  • Saint Francis Hospital and Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rotational atherectomy + cutting balloon

rotational atherectomy + plain old balloon

Arm Description

angioplasty with rotational atherectomy followed by cutting balloon

angioplasty with rotational atherectomy followed by plain old balloon

Outcomes

Primary Outcome Measures

Minimum Stent Area after Percutaneous Coronary Intervention
mm^2

Secondary Outcome Measures

In-segment Minimum lumen area after stent implantation
mm^2
In-segment Minimum lumen area assessed post-dilatation
mm^2
Minimum stent expansion after Percutaneous Coronary Intervention
mm^2
Mean stent expansion after Percutaneous Coronary Intervention
in %
Number of Participants with Dissection
A dissection or tear in the vessel wall
Number of Participants with Stent fracture
Stent fracture as a cause of drug-eluting stent failure
Number of Participants with Stent malapposition
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.
Acute lumen gain after stent implantation
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).

Full Information

First Posted
April 14, 2021
Last Updated
September 19, 2023
Sponsor
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
search

1. Study Identification

Unique Protocol Identification Number
NCT04865588
Brief Title
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Acronym
ROTA-CUT
Official Title
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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 artherectomy 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 artherectomy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis
Keywords
calcified plaque, angioplasty, cutting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rotational atherectomy + cutting balloon
Arm Type
Active Comparator
Arm Description
angioplasty with rotational atherectomy followed by cutting balloon
Arm Title
rotational atherectomy + plain old balloon
Arm Type
Active Comparator
Arm Description
angioplasty with rotational atherectomy followed by plain old balloon
Intervention Type
Procedure
Intervention Name(s)
rotational atherectomy
Intervention Description
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
Intervention Type
Device
Intervention Name(s)
cutting balloon
Intervention Description
a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
Intervention Type
Device
Intervention Name(s)
plain old balloon
Intervention Description
current standard treatment of stent placement
Primary Outcome Measure Information:
Title
Minimum Stent Area after Percutaneous Coronary Intervention
Description
mm^2
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
In-segment Minimum lumen area after stent implantation
Description
mm^2
Time Frame
Day 0
Title
In-segment Minimum lumen area assessed post-dilatation
Description
mm^2
Time Frame
Day 0
Title
Minimum stent expansion after Percutaneous Coronary Intervention
Description
mm^2
Time Frame
Day 0
Title
Mean stent expansion after Percutaneous Coronary Intervention
Description
in %
Time Frame
Day 0
Title
Number of Participants with Dissection
Description
A dissection or tear in the vessel wall
Time Frame
Day 0
Title
Number of Participants with Stent fracture
Description
Stent fracture as a cause of drug-eluting stent failure
Time Frame
Day 0
Title
Number of Participants with Stent malapposition
Description
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.
Time Frame
Day 0
Title
Acute lumen gain after stent implantation
Description
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).
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samin K Sharma, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Saint Francis Hospital and Heart Center
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs