The Restoring coronary arteries with drug eluting resorbable stents compared to metal stents in patients with diffuse narrowing. The RESTORE feasibility study

Phase 4

• Conditions: Subjects with diffuse left anterior descending artery disease that is not attractive for surgical revascularization; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12616000025437
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Diffuse LAD disease greater than or equal 50mm in length that is not attractive for surgical revascularisation due to LAD anatomy as judged by a cardiothoracic surgeon.
2. Reconstruction of the LAD with BRS is technically feasible as judged by an experienced BRS implanter.
3. Preserved antero-apical wall motion

Exclusion Criteria

1. Reconstruction of the LAD with BVS is not technically feasible due to deliverability.
2. Significally impaired LV systolic function of the anterior wall without demonstrable ischaemia (FFR <0.80 or moderate to large reversible perfusion defect on ischameia testing in the LAD territory)
3. Unable or unlikely to take or tolerate long term DAPT
4. Intolerance to Everolimus
5. Unlikely to survive the duration of the study due to othe comorbidity
6. Advanced renal disease not on haemodialysis (eGFR <30ml/min)
7. Within 48 hour of STEMI
8. Prior revascularisation of the mid to distal LAD with stents or CABG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: Anatomical suitability of the LAD for a LIMA anastomosis as assessed on CT coronary angiography after 2 years.<br>[Two years post procedure];Safety: MACE (all cause death,MI,or Target vessel revascularisation) after 2 years.[Two years post procedure]

Secondary Outcome Measures

Name	Time	Method
First occurence of angina pectoris assessed by Seattle questionaire<br>[One and two years post procedure];Target vessel MACE by review of hospital records[Two years post procedure];Left Ventricular function on echocardiography<br>[Two years post procedure];All MACE as per hospital records and mortality register[Two years post procedure];All cause death as per hospital records and mortality register[Two years post procedure];Stent thrombosis as per review of hospital records[Two years post procedure]