rotational atherectomy combined with cutting balloon to optimize stent expansion in calcified lesions

Conditions: Coronary Artery Disease; Atherosclerosis

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.

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)

Keywords: calcified plaque angioplasty cutting balloon