Drug Eluting Stents (DES)STRUT-OCTNCT01962740
Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
A study testing Drug-eluting stent implantation in people with Drug Eluting Stents (DES) and Percutaneous Coronary Intervention (PCI), run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Drug Eluting Stents (DES), Percutaneous Coronary Intervention (PCI), Uncovered and Malapposed Stent Struts
- What is being tested?
- Drug-eluting stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2015
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Clinical need for percutaneous coronary intervention using either a Xience, Promus Element, or Resolute Integrity drug-eluting stent using optical coherence tomography optimization
- Native coronary artery de novo lesion with ≥70% angiographic percent diameter stenosis by visual estimation
- Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
- Target lesion ≤28 mm in length by visual estimate
- Agree to participate and provide informed consent
Who cannot join
- 1.Presentation with acute ST-elevation myocardial infarction (defined as electrocardiographic (ECG) ST-elevation ≥ 2 mm in 2 or more contiguous ECG leads along with symptoms compatible with ischemia)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Health Care System
Dallas, Texas, 75216
About this study
Official title: Serial Evaluation of Drug-Eluting Stents Using OCT
The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)] at 6 weeks post implantation.
Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks post-implantation.
- Conditions
- Drug Eluting Stents (DES), Percutaneous Coronary Intervention (PCI), Uncovered and Malapposed Stent Struts, Optical Coherence Tomography (OCT)
- Being tested
- Drug-eluting stent implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting stent implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Xience EES | Active comparator | This arm of patients will receive Xience Everolimus Eluting Stents(EES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging Receives: Device: Drug-eluting stent implantation |
| Resolute Integrity ZES | Active comparator | This arm of patients will receive Resolute Integrity Zotaralimus Eluting Stents (ZES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging Receives: Device: Drug-eluting stent implantation |
| Promus Element EES | Active comparator | This arm of patients will receive Promus Element Everolimus Eluting Stents (EES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging Receives: Device: Drug-eluting stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Strut Coverage
Measured: 6 weeks post-implantation
Stent Strut Malapposition
Measured: 6 weeks post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionMar 2015
Why it stopped: Lack of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Eluting Stents (DES)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Shuaib Abdullah, MD, North Texas Veterans Healthcare System
- Investigators
- Shuaib Abdullah, MD, Principal investigator, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962740
- Sponsor's protocol ID
- 13-043
- Acronym
- STRUT-OCT
- Status last verified
- Jun 2016
- First submitted
- 8 Oct 2013
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Evaluation of Drug-Eluting Stents Using OCT
- ClinicalTrials.gov ID
- NCT01962740
- Acronym / sponsor ID
- STRUT-OCT / 13-043
- Conditions
- Drug Eluting Stents (DES), Percutaneous Coronary Intervention (PCI), Uncovered and Malapposed Stent Struts, Optical Coherence Tomography (OCT)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 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.
The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)] at 6 weeks post implantation.
Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks post-implantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xience EES | Active comparator | Device: Drug-eluting stent implantationThis arm of patients will receive Xience Everolimus Eluting Stents(EES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging |
| Resolute Integrity ZES | Active comparator | Device: Drug-eluting stent implantationThis arm of patients will receive Resolute Integrity Zotaralimus Eluting Stents (ZES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging |
| Promus Element EES | Active comparator | Device: Drug-eluting stent implantationThis arm of patients will receive Promus Element Everolimus Eluting Stents (EES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Clinical need for percutaneous coronary intervention using either a Xience, Promus Element, or Resolute Integrity drug-eluting stent using optical coherence tomography optimization
- Native coronary artery de novo lesion with ≥70% angiographic percent diameter stenosis by visual estimation
- Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
- Target lesion ≤28 mm in length by visual estimate
Key exclusion criteria (1 listed)
- 1.Presentation with acute ST-elevation myocardial infarction (defined as electrocardiographic (ECG) ST-elevation ≥ 2 mm in 2 or more contiguous ECG leads along with symptoms compatible with ischemia)
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 |
|---|---|---|
| Drug-eluting stent implantation | Device | Promus Element EES, Resolute Integrity ZES, Xience EES |
Primary outcome
Stent Strut Coverage
Time frame: 6 weeks post-implantation
Stent Strut Malapposition
Time frame: 6 weeks post-implantation
Results and safety
The study was stopped early (reason given: Lack of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: No
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STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
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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.
Shuaib Abdullah, MD principal investigator
North Texas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting stent implantation in people with Drug Eluting Stents (DES) and Percutaneous Coronary Intervention (PCI), run by North Texas Veterans Healthcare System at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 29 Jun 2016. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of eligible patients). 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?
Stent Strut Coverage (time frame: 6 weeks post-implantation). 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 29 Jun 2016.