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

July 2, 2015 updated by: GGuagliumi, A.O. Ospedale Papa Giovanni XXIII

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • A.O. Ospedale Papa Giovanni XXIII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: EES SYNERGY™
coronary artery lesions treated with Bioabsorbable Polymer EES
Device: EES SYNERGY™
percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES
ACTIVE_COMPARATOR: ZES, RESOLUTE Integrity™
coronary artery lesions treated with ZES, RESOLUTE Integrity™ stent system
Device: ZES, RESOLUTE Integrity™
percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA)
Time Frame: 18 months
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
Time Frame: 3 and 18 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
percent well apposed struts at implant without neointima
Time Frame: 3 and 18 months
OCT derived proportion of well apposed struts at implant without neointima (% uncovered struts) at 3 and 18 months
3 and 18 months
Acquired stent malapposition
Time Frame: 3 and 18 moths
Number and extent (max area-volume) of newly acquired malapposed struts at 3 and 18 months.
3 and 18 moths
OCT derived abnormal intraluminal tissue
Time Frame: 3 and 18 months
Presence of any abnormal intraluminal protruding mass at 3 and 18 months
3 and 18 months
percentage OCT frames with uncovered struts
Time Frame: 3 and 18 months
Number/percentage of OCT frames with > 30% uncovered struts at 3 and 18 months
3 and 18 months
Neointimal tissue thickness
Time Frame: 3 and 18 months
OCT calculated thickness of tissue covering stents at 3 and 18 months
3 and 18 months
OCT derived percentage of frames with mature neointima
Time Frame: 3 and 18 months
Percentage of frames with evidence of mature neointimal coverage in the two stent arms
3 and 18 months
OCT derived tissue heterogeneity in neointima deposition
Time Frame: 3 and 18 moths
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
3 and 18 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
A.O. Ospedale Papa Giovanni XXIII

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giulio Guagliumi, MD, A.O. Papa Giovanni XXIII, Cardiovascular Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRANSFORM 1207/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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