Status:
COMPLETED
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Lead Sponsor:
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
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 implant...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04865588
Start Date
May 13 2022
End Date
December 12 2023
Last Update
May 22 2024
Active Locations (2)
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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