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.
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;
Show all 17Show fewer
- 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.
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.
- Conditions
- Coronary Artery Lesions
- 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 group | Role | What they receive |
|---|---|---|
| EES SYNERGY™ | Experimental | coronary artery lesions treated with Bioabsorbable Polymer EES Receives: Device: EES SYNERGY™ |
| ZES, RESOLUTE Integrity™ | Active comparator | coronary 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.
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
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)
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
Acquired stent malapposition
Number and extent (max area-volume) of newly acquired malapposed struts at 3 and 18 months.
Measured: 3 and 18 moths
OCT derived abnormal intraluminal tissue
Presence of any abnormal intraluminal protruding mass at 3 and 18 months
Measured: 3 and 18 months
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
Neointimal tissue thickness
OCT calculated thickness of tissue covering stents at 3 and 18 months
Measured: 3 and 18 months
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
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.
- First posted30 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GGuagliumi, A.O. Ospedale Papa Giovanni XXIII
- Investigators
- Giulio Guagliumi, MD, Principal investigator, A.O. Papa Giovanni XXIII, Cardiovascular Department
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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™).
- ClinicalTrials.gov ID
- NCT01972022
- Acronym / sponsor ID
- TRANSFORM / TRANSFORM 1207/2013
- Conditions
- Coronary Artery Lesions
- Keywords
- Drug Eluting Stents, Bioabsorbale Polymer Coating, Neoatherosclerosis, Stent Coverage, Stent Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EES SYNERGY™ | Experimental | Device: EES SYNERGY™coronary artery lesions treated with Bioabsorbable Polymer EES |
| ZES, RESOLUTE Integrity™ | Active comparator | Device: ZES, RESOLUTE Integrity™coronary artery lesions treated with ZES, RESOLUTE Integrity™ stent system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EES SYNERGY™percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES | Device | EES SYNERGY™ |
| ZES, RESOLUTE Integrity™percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent | Device | ZES, RESOLUTE Integrity™ |
Primary outcome
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)
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)
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Related trials for Coronary Artery Lesions
Recruiting
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Coronary Artery Disease
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Not yet recruiting
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
Coronary Artery Disease (CAD)
RecruitingObservational study
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
Coronary Artery Disease
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulio Guagliumi, MD principal investigator
A.O. Papa Giovanni XXIII, Cardiovascular Department
1 site in 1 country: see every site and its status.
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?
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.