TRANSFORM OCT TRiple Assessment of Neointima Stent FOrmation to Reabsorbable polyMer With Optical Coherence Tomography

NCT01972022 | Unknown Phase 4 DMC

• 1 other identifier: TRANSFORM 1207/2013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Lesions

Keywords

Drug Eluting Stents; Bioabsorbale Polymer Coating; Neoatherosclerosis; Stent Coverage; Stent Failure

Outcome Measures

Primary Outcomes (2)

• percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA)

  OCT finding of neoatherosclerosis, counted as percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA) (18 month primary end-point)

  18 months

• length of consecutive frames with uncovered struts

  OCT derived maximum length of consecutive frames with uncovered struts in the two stent arms at 3 and 18 month (3 month primary end-point and 18 months co-primary end-points)

  3 and 18 months

Secondary Outcomes (7)

• percent well apposed struts at implant without neointima

  3 and 18 months

• Acquired stent malapposition

  3 and 18 moths

• OCT derived abnormal intraluminal tissue

  3 and 18 months

• percentage OCT frames with uncovered struts

  3 and 18 months

• Neointimal tissue thickness

  3 and 18 months

Study Arms (2)

EES SYNERGY™

EXPERIMENTAL

coronary artery lesions treated with Bioabsorbable Polymer EES

Device: EES SYNERGY™

ZES, RESOLUTE Integrity™

ACTIVE COMPARATOR

coronary artery lesions treated with ZES, RESOLUTE Integrity™ stent system

Device: ZES, RESOLUTE Integrity™

Interventions

EES SYNERGY™ DEVICE

percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES

EES SYNERGY™

ZES, RESOLUTE Integrity™ DEVICE

percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent

ZES, RESOLUTE Integrity™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age;
• 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;
• Target lesion stenosis is ≥ 70% (visual estimate)
• All target lesions require treatment with stents having diameters from 2.25 mm to 4.0 mm (visual estimate)
• Target lesion length ≥10 mm and ≤50 mm for each target lesion(s)
• Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
• Subject must be willing and able to comply with specified follow-up schedule.

You may not qualify if:

• Unprotected left main coronary disease;
• Chronic total occlusion;
• Severe calcified target lesion(s) which cannot be, in the investigator's opinion, successfully treated;
• Significant angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
• Bifurcation disease involving a side branch ≥ 2.5 mm in diameter;
• Restenotic lesions;
• Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft);
• In the Investigator's opinion, the lesion is not suitable for stenting or OCT imaging (e.g. extreme tortuosity, very distal lesions).
• Documented left ventricular ejection fraction ≤30%;
• Serum creatinine \> 2.0 mg/dl at the time of treatment;
• Recipient of heart transplant;
• 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;
• Known bleeding or hyper-coagulable disorder;
• Known allergy to stent components or any antiplatelet recommended drug
• Planned medical or surgical procedures requiring modification of DAPT regimen within 3 months after the index procedure;

Sponsors & Collaborators

• A.O. Ospedale Papa Giovanni XXIII: lead

Study Sites (1)

A.O. Ospedale Papa Giovanni XXIII

Bergamo, Bergamo, 24127, Italy

Location

Study Officials

• Giulio Guagliumi, MD

  A.O. Papa Giovanni XXIII, Cardiovascular Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 3, 2015

Record last verified: 2015-03

Locations

IT (1)