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

ID#: NCT04865588

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 13, 2022

End Date: December 01, 2023

Contact Information:
Regina Hanstein
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.
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)