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

Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Participants are randomised 1:1 ratio to reconstruction of the Left Anterior Descending (LAD) with everolimus eluting bioreabsorbable scaffolds or everolimus eluting metal stents. The ABSORB bioreabsorbable scaffold will be used. Stents are implanted during a percutaneous coronary intervention (PCI) via catheters placed up a major artery from the wrist or groin under local anaesthetic. The implantation procedure is very similar to that of other stents such as the Xience everolimus eluting metallic stents used in the control arm. Procedure duration may vary depending on the complexity of the lesion. CONDITION: Subjects with diffuse left anterior descending artery disease that is not attractive for surgical revascularization PRIMARY OUTCOME: Efficacy: Anatomical suitability of the LAD for a LIMA anastomosis as assessed on CT coronary angiography after 2 years. ; Safety: MACE (all cause death,MI,or Target vessel revascularisation) after 2 years. SECONDARY OUTCOME: All cause death as per hospital records and mortality register All MACE as per hospital records and mortality register First occurence of angina pectoris assessed by Seattle questionaire ; Left Ventricular function on echocardiography ; Stent thrombosis as per review of hospital records Target vessel MACE by review of hospital records 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
Epistemonikos ID: a64d26377351a3585fdf418fcdc3645053d2072d
First added on: Aug 24, 2024