Coronary Artery DiseaseOFDI-DMNCT01794949
Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement
A study testing Resolute Integrity stent in people with Coronary Artery Disease, run by Emory University at 1 site in United States.
Trial summary
The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Resolute Integrity stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient requiring percutaneous transluminal coronary interventions (PTCI) for acute coronary syndrome (ACS) and meeting criteria (as determined by the performing physician) for Resolute Integrity stent placement.
Who cannot join
- ST segment elevation MI (STEMI)
- stable angina
- current or planned pregnancy (for women of childbearing age)
- treatment of > 2 lesions during the index hospitalization
- insulin dependent diabetic patients at the time of stent placement
- use of overlapping stents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital Midtown
Atlanta, Georgia, 30308
About this study
Official title: Optical Frequency Domain Imaging (OFDI) Determined Stent Strut Coverage and Plaque Morphology After RESOLUTE Stent Placement in Non-Insulin Dependent Diabetics Presenting With Acute Coronary Syndrome (ACS)
The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications such as clot formation on the stent which may lead to a heart attack. Diabetic patients and those presenting with a heart attack at the time of stent placement are at increased risk for clot formation. However, little is known of the healing responses after stent placement in these populations.
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners, thereby improving the long-term safety of DES.
Read more
Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both preclinical and clinical studies.
The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, in this observational study, the study team will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement.
The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements.
Read the detailed description
The long-term efficacy of drug eluting stents (DES) used to treat symptomatic coronary artery disease is limited by incomplete healing of the stented segment necessitating the use of dual anti-platelet therapy (DAPT) with aspirin and a thienopyridine to prevent these late thrombotic complications. Diabetic patients and those presenting with acute coronary syndrome (ACS) at the time of DES placement are at increased risk for late in stent thrombosis, however, little is known of the healing responses in these populations.
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both thrombosis and bleeding, thereby improving the long-term safety of DES. Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging modality with the potential to discern plaque morphology at stent placement and stent strut healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE, Medtronic, Minneapolis, MN) has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies.
The purpose of this trial is to determine the healing responses to the RESOLUTE stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, investigators will 1) determine while using OFDI whether any difference in healing occurs in non-insulin dependent diabetic patients presenting with ACS after RESOLUTE stent placement at 6 months; 2) determine how initial plaque morphology and angiographic measures such as late loss correlate with stent strut healing; and 3) examine whether selected biomarkers have an utility in predicting stent strut healing by OFDI.
Investigators will conduct a clinical study that images subjects at baseline and at 6 months after stent placement with intracoronary OFDI. OFDI data will be utilized to determine plaque morphology prior to intervention, ensure adequate strut apposition and stent sizing immediately post deployment and to measure stent strut coverage at 6 month follow-up. Two follow-up imaging passes will be conducted to evaluate test-retest variability of the coverage measurement. In addition to assessing the feasibility of using the OFDI coverage metric in vivo, this data may provide information on the magnitude of coverage that can be expected at 6 months following RESOLUTE stents.
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Integrity stent
- Keywords
- Angioplasty, Atherosclerosis, Wound Healing
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute Integrity stentDevice
Drug eluting stents used to treat coronary artery blockages
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic patients receiving the Resolute stent | Experimental | Non-diabetic patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent. Receives: Device: Resolute Integrity stent |
| Diabetic patients receiving the Resolute stent | Experimental | Non-insulin dependent diabetes mellitus (NIDDM) patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent. Receives: Device: Resolute Integrity stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Stent Coverage
Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry A Liberman, Emory University
- Investigators
- Henry Liberman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794949
- Sponsor's protocol ID
- IRB00057208
- Acronym
- OFDI-DM
- Status last verified
- Apr 2017
- First submitted
- 7 Nov 2012
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.
PubMed 20129551Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
PubMed 17438147
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Frequency Domain Imaging (OFDI) Determined Stent Strut Coverage and Plaque Morphology After RESOLUTE Stent Placement in Non-Insulin Dependent Diabetics Presenting With Acute Coronary Syndrome (ACS)
- ClinicalTrials.gov ID
- NCT01794949
- Acronym / sponsor ID
- OFDI-DM / IRB00057208
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Atherosclerosis, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications such as clot formation on the stent which may lead to a heart attack. Diabetic patients and those presenting with a heart attack at the time of stent placement are at increased risk for clot formation. However, little is known of the healing responses after stent placement in these populations.
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners, thereby improving the long-term safety of DES.
Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both preclinical and clinical studies.
The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, in this observational study, the study team will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement.
The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements.
Detailed description
The long-term efficacy of drug eluting stents (DES) used to treat symptomatic coronary artery disease is limited by incomplete healing of the stented segment necessitating the use of dual anti-platelet therapy (DAPT) with aspirin and a thienopyridine to prevent these late thrombotic complications. Diabetic patients and those presenting with acute coronary syndrome (ACS) at the time of DES placement are at increased risk for late in stent thrombosis, however, little is known of the healing responses in these populations.
Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both thrombosis and bleeding, thereby improving the long-term safety of DES. Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging modality with the potential to discern plaque morphology at stent placement and stent strut healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE, Medtronic, Minneapolis, MN) has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies.
The purpose of this trial is to determine the healing responses to the RESOLUTE stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, investigators will 1) determine while using OFDI whether any difference in healing occurs in non-insulin dependent diabetic patients presenting with ACS after RESOLUTE stent placement at 6 months; 2) determine how initial plaque morphology and angiographic measures such as late loss correlate with stent strut healing; and 3) examine whether selected biomarkers have an utility in predicting stent strut healing by OFDI.
Investigators will conduct a clinical study that images subjects at baseline and at 6 months after stent placement with intracoronary OFDI. OFDI data will be utilized to determine plaque morphology prior to intervention, ensure adequate strut apposition and stent sizing immediately post deployment and to measure stent strut coverage at 6 month follow-up. Two follow-up imaging passes will be conducted to evaluate test-retest variability of the coverage measurement. In addition to assessing the feasibility of using the OFDI coverage metric in vivo, this data may provide information on the magnitude of coverage that can be expected at 6 months following RESOLUTE stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic patients receiving the Resolute stent | Experimental | Device: Resolute Integrity stentNon-diabetic patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent. |
| Diabetic patients receiving the Resolute stent | Experimental | Device: Resolute Integrity stentNon-insulin dependent diabetes mellitus (NIDDM) patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient requiring percutaneous transluminal coronary interventions (PTCI) for acute coronary syndrome (ACS) and meeting criteria (as determined by the performing physician) for Resolute Integrity stent placement.
Key exclusion criteria (6 listed)
- ST segment elevation MI (STEMI)
- stable angina
- current or planned pregnancy (for women of childbearing age)
- treatment of > 2 lesions during the index hospitalization
- insulin dependent diabetic patients at the time of stent placement
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 |
|---|---|---|
| Resolute Integrity stentDrug eluting stents used to treat coronary artery blockages | Device | Diabetic patients receiving the Resolute stent, Non-diabetic patients receiving the Resolute stent |
Primary outcome
Percent Stent Coverage
Time frame: 6 months
Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20129551Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.
- Background: PubMed 17438147Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
- Individual participant dataSharing planned: Undecided
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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.
Henry Liberman, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Integrity stent in people with Coronary Artery Disease, run by Emory University 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 15 May 2017. 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?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Stent Coverage (time frame: 6 months). 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 NCT01794949, 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 15 May 2017.