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Coronary Artery LesionsPhase 4TRANSFORMNCT01972022

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

A Phase 4 study testing EES SYNERGY™ and ZES, RESOLUTE Integrity™ in people with Coronary Artery Lesions, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Lesions
What is being tested?
EES SYNERGY™ and ZES, RESOLUTE Integrity™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteItaly
Study dates
Nov 2013to Sep 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Women of childbearing potential without negative pregnancy test within 7 days before enrollment
  • Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • A.O. Ospedale Papa Giovanni XXIII

    Bergamo, Bergamo, 24127

Other trials in Italy

About this study

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™).

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.

Read the detailed 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.

Being tested
EES SYNERGY™, ZES, RESOLUTE Integrity™
Keywords
Drug Eluting Stents, Bioabsorbale Polymer Coating, Neoatherosclerosis, Stent Coverage, Stent Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EES SYNERGY™Device

    percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES

  • ZES, RESOLUTE Integrity™Device

    percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent

Study groups in NCT01972022
Study groupRoleWhat they receive
EES SYNERGY™Experimentalcoronary artery lesions treated with Bioabsorbable Polymer EES
Receives: Device: EES SYNERGY™
ZES, RESOLUTE Integrity™Active comparatorcoronary artery lesions treated with ZES, RESOLUTE Integrity™ stent system
Receives: Device: ZES, RESOLUTE Integrity™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 18 months

  2. 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)

    Measured: 3 and 18 months

Secondary outcomes (7)

  1. percent well apposed struts at implant without neointima

    OCT derived proportion of well apposed struts at implant without neointima (% uncovered struts) at 3 and 18 months

    Measured: 3 and 18 months

  2. Acquired stent malapposition

    Number and extent (max area-volume) of newly acquired malapposed struts at 3 and 18 months.

    Measured: 3 and 18 moths

  3. OCT derived abnormal intraluminal tissue

    Presence of any abnormal intraluminal protruding mass at 3 and 18 months

    Measured: 3 and 18 months

  4. percentage OCT frames with uncovered struts

    Number/percentage of OCT frames with > 30% uncovered struts at 3 and 18 months

    Measured: 3 and 18 months

  5. Neointimal tissue thickness

    OCT calculated thickness of tissue covering stents at 3 and 18 months

    Measured: 3 and 18 months

  6. OCT derived percentage of frames with mature neointima

    Percentage of frames with evidence of mature neointimal coverage in the two stent arms

    Measured: 3 and 18 months

  7. OCT derived tissue heterogeneity in neointima deposition

    Segmental tissue heterogeneity in neointima deposition across the entire stent length (as assessed by OCT tissue properties parameters - including normalized intensity, attenuation, tissue contrast) at 3 and 18 months

    Measured: 3 and 18 moths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972022
Sponsor's protocol ID
TRANSFORM 1207/2013
Acronym
TRANSFORM
Status last verified
Mar 2015
First submitted
24 Oct 2013
Last updated
3 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EES SYNERGY™ and ZES, RESOLUTE Integrity™ in people with Coronary Artery Lesions, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01972022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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