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

Sponsor
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04865588
Collaborator
(none)
60
2
2
18.6
30
1.6

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Procedure: rotational atherectomy
  • Device: cutting balloon
  • Device: plain old balloon
N/A

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. 30 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Actual Study Start Date :
May 13, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Minimum Stent Area after Percutaneous Coronary Intervention [Day 0]

    mm^2

Secondary Outcome Measures

  1. In-segment Minimum lumen area after stent implantation [Day 0]

    mm^2

  2. In-segment Minimum lumen area assessed post-dilatation [Day 0]

    mm^2

  3. Minimum stent expansion after Percutaneous Coronary Intervention [Day 0]

    mm^2

  4. Mean stent expansion after Percutaneous Coronary Intervention [Day 0]

    in %

  5. Number of Participants with Dissection [Day 0]

    A dissection or tear in the vessel wall

  6. Number of Participants with Stent fracture [Day 0]

    Stent fracture as a cause of drug-eluting stent failure

  7. Number of Participants with Stent malapposition [Day 0]

    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.

  8. Acute lumen gain after stent implantation [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Icahn School of Medicine at Mount Sinai New York New York United States 10029
2 Saint Francis Hospital and Heart Center Roslyn New York United States 11576

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I., Professor of Medicine/Cardiology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT04865588
Other Study ID Numbers:
  • GCO 21-0532
First Posted:
Apr 29, 2021
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Samin Sharma, M.D., F.A.C.C., M.S.C.A.I., Professor of Medicine/Cardiology, Icahn School of Medicine at Mount Sinai
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022