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Coronary Artery DiseasePhase 4LONG OCTNCT01133925

Optical Coherence Tomography in Long Lesions

A Phase 4 study testing Resolute Sprint, Sirolimus Eluting Stent and Paclitaxel Eluting Stent in people with Coronary Artery Disease, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Resolute Sprint, Sirolimus Eluting Stent and Paclitaxel Eluting Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteItaly
Study dates
May 2008to May 2011
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

  • Patient must be at least 18 years of age
  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
  • Native coronary artery disease with >75% diameter stenosis (no prior stent implant, no prior brachytherapy)
  • Lesion length > 20 mm
  • Vessel size between 2.5 and 3.5 mm
  • Multiple, overlapped Endeavor Resolute stents placement (intention to overlap > 4 mm).

Who cannot join

  • Left main coronary artery disease
  • Lesions in coronary artery bypass grafts
  • Acute myocardial infarction
  • Killip class IV
  • Recent major bleeding (6 months)
  • Renal failure with creatinine value > 2.5 mg/dl
Show all 13Show fewer
  • Left ventricular global ejection fraction ≤ 30%.
  • Allergy to aspirin and or clopidogrel/ticlopidine
  • Patient in anticoagulant therapy
  • No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [> 3.5 mm in diameter])
  • Target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) < 9 months prior to index procedure
  • Target lesion restenotic from previous stent implantation
  • Any lesion (target or non-target) that has been previously treated with brachytherapy

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Cardiovascular Department Ospedali Riuniti di Bergamo

    Bergamo, BG, 24128

Other trials in Italy

About this study

Official title: Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY

Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively assigned to receive multiple zotarolimus eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will be compared to the historical arm of ODESSA trial (patients treated with multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).

Read the detailed description

It is not unknown whether overlapping drug-eluting stents provide increased vessel toxicity. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detects smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition.

Patients if eligible on the basis of clinical and angiographic criteria, are assigned to receive multiple Resolute Sprint™. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis < 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.

OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of > 30% uncovered struts/total number of struts per section.

Obtained data will be compared with the data from a historical comparator (ODESSA trial that presented results from TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ stents implanted in overlap to treat long lesions.

Being tested
Resolute Sprint, Sirolimus Eluting Stent, Paclitaxel Eluting Stent, Zotarolimus eluting stent
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Eluting Stent, Optical Coherence Tomography, Thrombosi, Long lesions in native vessels requiring overlap
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Resolute SprintDevice

    Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

  • Sirolimus Eluting StentDevice

    Cypher stents implanted in overlap

  • Paclitaxel Eluting StentDevice

    Taxus stents implanted in overlap

  • Zotarolimus eluting stentDevice

    Endeavor stents implanted in overlap

Study groups in NCT01133925
Study groupRoleWhat they receive
ODESSAActive comparatorODESSA trial (NCT 00693030)Patients were randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. At 6-months follow-up coronary angiography (QCA), IVUS and Optical Coherence Tomography assessments were made. Data reported in J. Am. Coll. Cardiol. Intv. 2010;3;531-539. DOI 10.1016/j.jcin.2010.02.008.
Receives: Device: Sirolimus Eluting Stent; Device: Paclitaxel Eluting Stent; Device: Zotarolimus eluting stent
Resolute Sprint armExperimentalZotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions
Receives: Device: Resolute Sprint

What is being measured

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

  1. In stent NIH at overlapping vs non overlapping sites

    In-stent neointimal hyperplasia (NIH) thickness at 6 months, as measured by OCT, at overlapping vs non overlapping sites: superiority of Endeavor Resolute stent compared to Endeavor Sprint

    Measured: 6 month

  2. Percent uncovered and malapposed struts in OCT

    Proportion of stent struts uncovered and/or malapposed at 6 months, as measured by OCT, at overlapping vs non overlapping sites: non inferiority of Endeavor Resolute compared to Endeavor Sprint.

    Measured: 6 month

Secondary outcomes (4)

  1. Rate of > 30% uncovered struts/total number of struts per section.

    Measured: 6 months

  2. MACE Rates

    All specific components of MACE (cardiac death, myocardial infarction (Q wave and non Q wave), and target vessel revascularization) will be summarized. MACE shall be assessed at, discharge (or within 7 days, whichever comes first), 1, 6 and 12 months post index procedure.

    Measured: 1-6 and 12 months

  3. IVUS parameters

    Based on IVUS Core Lab analysis including:

    • Neointimal volume, stent volume, lumen volume and percent net volume obstruction
    • Neointimal Thickness: Neointimal hyperplasia (NIH) inside all struts (mean, median, max)
    • Percent NIH Area= ([stent area-lumen area]/stent area) X 100
    • Rate of > 30% uncovered struts/total number of struts per section.

    Measured: 6 months

  4. QCA Parameters

    Based on Angiographic Core Lab analysis utilizing Quantitative Coronary Angiography (QCA) including:

    Mean lumen diameter, acute gain, late loss through 6 months, and binary restenosis (≥ 50% diameter stenosis) rate at 6 months post index procedure.

    Measured: 6 months

Timeline

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

  1. First posted31 May 2010 (estimated)
  2. Study startMay 2008
  3. Primary completionAug 2009
  4. Study completionMay 2011 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01133925
Sponsor's protocol ID
BG-003-08
Acronym
LONG OCT
Status last verified
May 2010
First submitted
28 May 2010
Last updated
31 May 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA; ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.

    PubMed 20488410

  • Guagliumi G, Ikejima H, Sirbu V, Bezerra H, Musumeci G, Lortkipanidze N, Fiocca L, Tahara S, Vassileva A, Matiashvili A, Valsecchi O, Costa M. Impact of drug release kinetics on vascular response to different zotarolimus-eluting stents implanted in patients with long coronary stenoses: the LongOCT study (Optical Coherence Tomography in Long Lesions). JACC Cardiovasc Interv. 2011 Jul;4(7):778-85. doi: 10.1016/j.jcin.2011.04.007.

    PubMed 21777886

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Resolute Sprint, Sirolimus Eluting Stent and Paclitaxel Eluting Stent in people with Coronary Artery Disease, 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 6 inclusion and 13 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 31 May 2010. 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?

In stent NIH at overlapping vs non overlapping sites (time frame: 6 month). 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 NCT01133925, which also lists 2 linked publications.

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 31 May 2010.

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