The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting
 bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients
 with complex de novo native coronary artery lesions in all-day clinical practice.
Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents
 (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery
 patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a
 result of everolimus release, neointimal growth is inhibited similar to DES. Finally the
 implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis
 may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and
 angulation as well as response to nitroglycerine and endothelial function.
The recommendation to implant BVS in an individual patient in whom rotational atherectomy
 of a complex target lesion has been conducted, is purely based on clinical grounds. These
 are determined by the instructions for use (IFU) of the BVS and by the clinical experience
 accumulated so far from clinical studies.These studies suggest that the BVS should be
 implanted under certain conditions, which are determined by the patient and the coronary
 lesion treated:

 Eligible:

 Regarding to patient

 -  Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic
 heart disease (chronic, NSTEMI and unstable angina) due to one or more complex de novo
 native coronary artery lesions

 -  Patients with evidence of myocardial ischemia

 Regarding to lesion

 -  Reference vessel diameter ≥ 2.5 mm and ≤ 3.8 mm, visually estimated or by online QCA

 -  Percent diameter stenosis ≥ 50% and < 100%, visually estimated or by online QCA

 -  TIMI ≥1

 -  Previous interventions of target vessel lesions should have been done ≥ 6 months prior
 to index procedure and > 10 mm distal to the target lesion

 -  Previous interventions of non-target vessel lesions should have been done ≥ 30 days
 prior to index procedure

 Not eligible:

 Regarding to patient

 -  Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated

 -  Patient with a known hypersensitivity or contraindication to aspirin, both heparin and
 bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly
 (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot
 be adequately premedicated

 -  Patient has a known diagnosis of acute myocardial infarction (STEMI) within 72 hours
 preceding the index procedure and CK and CK-MB have not returned within normal limits
 at the time of procedure

 -  Patient is currently experiencing clinical symptoms consistent with STEMI

 -  Patient has current unstable arrhythmias

 -  Patient has a known left ventricular ejection fraction < 30%

 -  Patient has received a heart transplant or any other organ transplant or is waiting
 for any organ transplant

 -  Patient receiving or scheduled to receive chemotherapy for malignancy within 30 days
 prior to or after procedure

 -  Patient is receiving immunosuppression therapy and has known immunosuppressive or
 autoimmune disease

 -  Patient is receiving or scheduled to receive chronic anticoagulation therapy

 -  Elective surgery is planned within the first 6 month after the procedure that will
 require discontinuing either aspirin or clopidogrel

 -  Patient has a platelet count < 100 000 cells/mm3 or > 700 000 cells/mm3, a WBC of

 -  < 3000 cells/mm3, or documented or suspected liver disease

 -  Patient has known renal insufficiency

 -  Patient has a history of bleeding diathesis or coagulopathy or will refuse blood
 transfusions

 -  Patient has cerebrovascular accident or transient ischemic neurological attack within
 the past six month

 -  Patient has had a significant GI or urinary bleed within the past six months

 -  Patient has extensive peripheral vascular disease that precludes safe 6 French sheath
 insertion

 -  Patient has other medical illness (e.g., cancer or congestive heart failure) or known
 history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
 noncompliance with the clinical study plan, confound the data interpretation or is
 associated with a limited life expectancy (i.e., les than one year)

 -  Women of childbearing potential who have not undergone surgical sterilization or are
 not post- menopausal

 Regarding to lesion

 Target lesion(s) meets none of the following criteria:

 -  Aorto-ostial location

 -  Left main location

 -  Located within 2 mm of the origin of LAD or LCX

 -  Located within an arterial or saphenous vein graft or distal to a diseased (defined as
 vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
 arterial or saphenous vein graft

 -  Ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation

 -  Excessive tortuosity proximal to or within the lesion (extreme angulation proximal to
 or within the lesion)

 -  Restenotic from previous intervention

 Target vessel is not containing thrombus