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

Coronary Artery Disease Clinical Trial

— ASSURE ROT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01915420
• Other study ID #: ASSURE ROT
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2013
• Last updated: February 5, 2015
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: February 2015
• Source: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Contact: Detlef G Mathey, Prof. Dr.
• Phone: +4940889009
• Email: dgmathey[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: August 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Heart Diseases
• Myocardial Ischemia
• Vascular Diseases

Locations

Country	Name	City	State
Germany	Medical Care Center Prof. Mathey, Prof. Schofer GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Basavarajaiah S, Naganuma T, Latib A, Colombo A. Can bioabsorbable scaffolds be used in calcified lesions? Catheter Cardiovasc Interv. 2014 Jul 1;84(1):48-52. doi: 10.1002/ccd.24939. Epub 2013 Aug 31. — View Citation

Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168. — View Citation

Patel N, Banning AP. Bioabsorbable scaffolds for the treatment of obstructive coronary artery disease: the next revolution in coronary intervention? Heart. 2013 Sep;99(17):1236-43. doi: 10.1136/heartjnl-2012-303346. Epub 2013 Mar 8. Review. — View Citation

Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Event (MACE)	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death	at 24 months	Yes
Secondary	Acute procedural success	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.	At the end of hospital stay (maximum of 7 days)	Yes
Secondary	Acute device success	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.	At time of intervention	No
Secondary	Scaffold thrombosis		At time of intervention, and at 6, 12, 24, and 36 months	Yes
Secondary	Cardiac death		At time of intervention, and at 6, 12,24, and 36 months	Yes
Secondary	Myocardial infarction		At time of intervention, and at 6, 12, 24, and 36 months	Yes
Secondary	Ischemia driven target lesion revascularisation (TLR)	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death	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	Yes
Secondary	Ischemia driven target vessel revascularisation (TVR)		at 6, 12, 24, and 36 month	Yes
Secondary	In-lesion % diameter stenosis	QCA: Independent CoreLab	Baseline and final at time of intervention and at 24 months FU	No
Secondary	Minimal lumen diameter (MLD)	QCA: Independent CoreLab	Baseline and final at time of intervention and at 24 months FU	No
Secondary	In-scaffold late lumen loss (LLL)		At 24 months FU	No