The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions

Sponsor

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01915420

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Restenosis Heart Diseases Coronary Stenosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Postmarketing Surveillance Registry to Monitor Everolimus-eluting Bioresorbable Vascular Scaffold Following Rotational Atherectomy for the Treatment of Complex Coronary Lesions - The ASSURE ROT Registry

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Aug 1, 2017

Outcome Measures

Primary Outcome Measures

Major Adverse Cardiac Event (MACE) [at 24 months]
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death

Secondary Outcome Measures

Acute procedural success [At the end of hospital stay (maximum of 7 days)]
Achievement of final in-scaffold residual stenosis of < 50% and TIMI flow 3 of the target site. Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet clinical procedure success criteria.
Acute device success [At time of intervention]
Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system. Attainment of < 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.
Scaffold thrombosis [At time of intervention, and at 6, 12, 24, and 36 months]
Cardiac death [At time of intervention, and at 6, 12,24, and 36 months]
Myocardial infarction [At time of intervention, and at 6, 12, 24, and 36 months]
Ischemia driven target lesion revascularisation (TLR) [At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 24, and 36 months]
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death
Ischemia driven target vessel revascularisation (TVR) [at 6, 12, 24, and 36 month]
In-lesion % diameter stenosis [Baseline and final at time of intervention and at 24 months FU]
QCA: Independent CoreLab
Minimal lumen diameter (MLD) [Baseline and final at time of intervention and at 24 months FU]
QCA: Independent CoreLab
In-scaffold late lumen loss (LLL) [At 24 months FU]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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