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

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

• Registration Number: NCT01915420
• Lead Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

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.

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 Timeline

• Study First Submitted: 2013-07-29
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-06
• Primary Completion: 2015-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
Myocardial infarction	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
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
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
Scaffold thrombosis	At time of intervention, and at 6, 12, 24, and 36 months
Ischemia driven target vessel revascularisation (TVR)	at 6, 12, 24, and 36 month

Trial Locations

Locations (1)

Medical Care Center Prof. Mathey, Prof. Schofer GmbH; 🇩🇪 Hamburg, Germany