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

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

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.

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)