Overview

This trial is active, not recruiting.

Condition coronary artery lesions
Treatments ees synergy™, zes, resolute integrity™
Phase phase 4
Sponsor A.O. Ospedale Papa Giovanni XXIII
Start date November 2013
End date March 2016
Trial size 90 participants
Trial identifier NCT01972022, TRANSFORM 1207/2013

Summary

First prospective randomized controlled study to evaluate in an 'all-comers' population with coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with respect to the long term vascular response to treatment These data are important to ascertain the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long term development of in-stent neoatherosclerosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
coronary artery lesions treated with Bioabsorbable Polymer EES
ees synergy™
percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES
(Active Comparator)
coronary artery lesions treated with ZES, RESOLUTE Integrity™ stent system
zes, resolute integrity™
percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent

Primary Outcomes

Measure
percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA)
time frame: 18 months
length of consecutive frames with uncovered struts
time frame: 3 and 18 months

Secondary Outcomes

Measure
percent well apposed struts at implant without neointima
time frame: 3 and 18 months
Acquired stent malapposition
time frame: 3 and 18 moths
OCT derived abnormal intraluminal tissue
time frame: 3 and 18 months
percentage OCT frames with uncovered struts
time frame: 3 and 18 months
Neointimal tissue thickness
time frame: 3 and 18 months
OCT derived percentage of frames with mature neointima
time frame: 3 and 18 months
OCT derived tissue heterogeneity in neointima deposition
time frame: 3 and 18 moths

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject is ≥18 years of age; 2. Subject has stable angina or acute coronary syndrome (including acute myocardial infarction) with evidence of coronary ischemia and de novo atherosclerotic coronary artery disease in multiple vessels with an indication for stent implantation; 3. Target lesion stenosis is ≥ 70% (visual estimate) 4. All target lesions require treatment with stents having diameters from 2.25 mm to 4.0 mm (visual estimate) 5. Target lesion length ≥10 mm and ≤50 mm for each target lesion(s) 6. Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure; 7. Subject must be willing and able to comply with specified follow-up schedule. Exclusion Criteria: 1. Unprotected left main coronary disease; 2. Chronic total occlusion; 3. Severe calcified target lesion(s) which cannot be, in the investigator's opinion, successfully treated; 4. Significant angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment; 5. Bifurcation disease involving a side branch ≥ 2.5 mm in diameter; 6. Restenotic lesions; 7. Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft); 8. In the Investigator's opinion, the lesion is not suitable for stenting or OCT imaging (e.g. extreme tortuosity, very distal lesions). 9. Documented left ventricular ejection fraction ≤30%; 10. Serum creatinine > 2.0 mg/dl at the time of treatment; 11. Recipient of heart transplant; 12. Subject with malignancies or other comorbidities (i.e. severe liver, renal, pulmonary, pancreatic disease) with life expectancy less than 18 months or that may results in protocol non-compliance; 13. Known bleeding or hyper-coagulable disorder; 14. Known allergy to stent components or any antiplatelet recommended drug 15. Planned medical or surgical procedures requiring modification of DAPT regimen within 3 months after the index procedure; 16. Women of childbearing potential without negative pregnancy test within 7 days before enrollment 17. Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints

Additional Information

Official title A Prospective Optical Coherence Tomography (OCT) Study on Coronary Vessel Wall Response to Stent Eluting Everolimus From a Biodegradable Polymer (EES SYNERGY™) Compared With Stent Eluting Zotarolimus From a Durable Polymer (ZES, RESOLUTE Integrity™).
Principal investigator Giulio Guagliumi, MD
Description During the last decade a considerable clinical experience has been accumulated with the use of drug eluting coronary stents with durable polymers, that permanently cover the metallic stent scaffold, allowing the local delivery of anti-restenotic agents. However durable polymers have been associated with an increased risk of late and very late stent thrombosis and the anticipated development of in stent neo-atherosclerosis. Since permanent polymer coatings may have pro-inflammatory effects, with delayed healing and prolonged endothelial dysfunction, current research on DES has focused on the use of biodegradable polymer coatings, which disappear after a short period of drug-release (3-4 months). Current clinical guidelines recommend at least 6-12 months of dual antiplatelet therapy (DAPT) after DES implantation,in order to prevent ST. Recent data obtained by pooled analyses of ZES, support a significant reduction of the DAPT to the same range used with bare metal stents. The substantial delays in DES healing observed from multiple human pathology series and in-vivo studies using Optical Coherence Tomography (OCT) were not assessed as risk factors for prolonged used of DAPT. However different patient cohorts might have different responses to stent implantation. In addition, there is no comparative evidence on long term development of neo-atherosclerosis in bioabsorbable versus permanent polymer DES. OCT allows precise assessment of stent strut apposition and coverage and accurate measures of different tissue components of neoatherosclerosis. This study is the first attempting to characterize the early and late vascular responses to novel bioabsorbable polymer EES (SYNERGY™) compared with a permanent polymer benchmark novel generation ZES (RESOLUTE INTEGRITY™) .The stent comparator has been selected due to the large use across the interventional cardiology community and the recent approval from European Regulators Authorities to update the CE (Conformité Européenne) mark labeling to only one-month duration of dual anti-platelet therapy.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by A.O. Ospedale Papa Giovanni XXIII.