Percutaneous Coronary InterventionSOLEMNNCT03474432
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
A study testing Optical Coherence Tomography in people with Percutaneous Coronary Intervention and Optical Coherence Tomography, run by Jesse Brown VA Medical Center at 13 sites in United States.
Trial summary
BACKGROUD: Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers. OCT allows for precise determination of stent placement, stent expansion and apposition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 13 sitesUnited States
- Study dates
- 11 Jul 2018to 31 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater;
- Left Main CAD, defined as ≥ 50% diameter stenosis and amenable to re-vascularization by PCI;
- Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- Ability to comply with minimum of 6 months of DAPT after the index procedure.
- Unprotected Left Main PCI
- Protected Left Main PCI
Who cannot join
- Coexisting conditions that limit life expectancy to less than 12 months or that could affect patient's compliance with the protocol;
- Serum creatinine greater than 2.0 mg/dL;
- Cardiogenic shock;
- STEMI;
- Non-STEMI, if the cardiac troponin is not stable or starting to decline;
- Pregnancy;
Show all 15Show fewer
- Inability to take dual antiplatelet therapy for 6 months;
- Any target lesion with previously placed stent.
- Patients disqualified for CABG surgery.
- Contraindications for OCT use:
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Severe hemodynamic instability or shock
- Patients diagnosed with coronary artery spasm
- Acute renal failure
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Atlanta VA Medical Center
Atlanta, Georgia, 30033
Birmingham VA Medical Center
Birmingham, Alabama, 35233
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Jesse Brown VAMC
Chicago, Illinois, 60025
VA Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
Dallas VA Medical Center
Dallas, Texas, 75216
VA Eastern Colorado Health Care System
Denver, Colorado, 80220
VA Long Beach Healthcare
Long Beach, California, 90822
Oklahoma City VA Health Care System
Oklahoma City, Oklahoma, 73104
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
San Antonio VA
San Antonio, Texas, 78028
San Francisco VA
San Francisco, California, 94121
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
BACKGROUD:
Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.
Read more
OCT allows for precise determination of stent placement, stent expansion and apposition. The pattern of vessel healing can be very precisely studied if immediate post-stent implantation OCT/IVUS data is compared to the 6-month post-PCI interval.
While OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image ostial lesions/stent placement.
Optimal and consistent vessel healing is particularly important in LM PCI where stent thrombosis is a potential complication with serious adverse outcome.
HYPOTHESIS:
Due to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early strut coverage patterns and timeline may be different than previously observed in DES and BMS stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from previous observations with traditional DES/BMS.
Stent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared to OCT or IVUS at the time of stent implantation.
OCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6 and 12 months.
Read the detailed description
The proposed study is a multicenter, observational, prospective, single-arm study of stent strut coverage of patients undergoing LM PCI.
Baseline quantitative coronary analysis (QCA) will be performed at the time of stent implantation.
Stent coverage in LM PCI will be studied with OCT at 3 and 12 months and compared to baseline OCT at the time of stent implantation.(31, 32)
OCT/data will be analyzed in a core lab (CTC CRF) and correlated with clinical outcomes at 3 and 12 months.
Primary Endpoint
- 3-month stent strut coverage in LM PCI
Secondary Endpoints
- 12-month stent strut coverage in LM PCI
- 3-month late acquired stent malapposition (LASM)
- 12-month late acquired stent malapposition (LASM)
- One-month LM Synergy stent safety
- 1-, 3- and 12-month MACE
- 1-, 3- and 12-month Stent Thrombosis (ST) (ARC definition) 75 patients undergoing LM PCI (protected or unprotected) with Boston Scientific Synergy™ stent.
The goal is to enroll 75 patients from up to 10 VA sites and an enrollment period of 3 years, each site is expected to include 7-10 patients during the study period.
After a total of 75 patients are enrolled the study will be closed for further enrollment.
Eligible patients will be screened at each participating center and those who had undergone LM PCI with Boston Scientific Synergy™ stent and where OCT was performed during the index procedure will be eligible. The index procedure may be performed by any interventional cardiologist - this is specifically needed in order to maintain equipoise on the part of stent choice and use of OCT.
At the end of the study enrollment period, the proportion of patients at each site treated with Synergy stents vs. non-Synergy stents and the proportion of patients that underwent OCT imaging during LM PCI will be collected.
Eligible patients will be approached and consented for inclusion in the SOLEMN trial after the initial procedure.
Study Duration
Patients will be followed for 12 months after the index procedure. At one month, clinical follow-up will be performed (clinic or telephone). At 3 months, the angiography and OCT will be performed. At 12 months, the final angiography and OCT will be performed. No further follow-up is planned after completion of the 3- and 12-month angiography and OCT.
- Conditions
- Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
- Being tested
- Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
Also called Dragonfly OPTIS Imaging Catheter
OCT will be performed with the St. Jude OCT system. Detection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography | Other | Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
The stents from 6 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.
Measured: 3 Months
Secondary outcomes (4)
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
The stents from 2 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.
Measured: 12 month
3-month Persistent Stent Malapposition
Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.
Measured: 3 month
12-month Persistent Stent Malapposition
Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.
Measured: 12 month
Major Adverse Cardiac Event (MACE)
MACE include:
- Death
- Myocardial infarction
- Stroke (cerebrovascular accident or CVA)
- Urgent revascularization
- Repeat revascularization
- Bleeding
- Stent thrombosis
- Rehospitalization
Measured: MACE reported at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start11 Jul 2018
- Primary completion31 Dec 2019
- Study completion31 May 2020
Why it stopped: Due to lack of enrollment.
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.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesse Brown VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mladen I. Vidovich, Jesse Brown VA Medical Center
- Investigators
- Mladen I Vidovich, MD, Principal investigator, Jesse Brown VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474432
- Sponsor's protocol ID
- JBVA-MIV-001
- Acronym
- SOLEMN
- Status last verified
- May 2024
- First submitted
- 2 Mar 2018
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
- ClinicalTrials.gov ID
- NCT03474432
- Acronym / sponsor ID
- SOLEMN / JBVA-MIV-001
- Conditions
- Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jesse Brown VA Medical CenterUS federal agency
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUD:
Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.
OCT allows for precise determination of stent placement, stent expansion and apposition. The pattern of vessel healing can be very precisely studied if immediate post-stent implantation OCT/IVUS data is compared to the 6-month post-PCI interval.
While OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image ostial lesions/stent placement.
Optimal and consistent vessel healing is particularly important in LM PCI where stent thrombosis is a potential complication with serious adverse outcome.
HYPOTHESIS:
Due to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early strut coverage patterns and timeline may be different than previously observed in DES and BMS stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from previous observations with traditional DES/BMS.
Stent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared to OCT or IVUS at the time of stent implantation.
OCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6 and 12 months.
Detailed description
The proposed study is a multicenter, observational, prospective, single-arm study of stent strut coverage of patients undergoing LM PCI.
Baseline quantitative coronary analysis (QCA) will be performed at the time of stent implantation.
Stent coverage in LM PCI will be studied with OCT at 3 and 12 months and compared to baseline OCT at the time of stent implantation.(31, 32)
OCT/data will be analyzed in a core lab (CTC CRF) and correlated with clinical outcomes at 3 and 12 months.
Primary Endpoint
- 3-month stent strut coverage in LM PCI
Secondary Endpoints
- 12-month stent strut coverage in LM PCI
- 3-month late acquired stent malapposition (LASM)
- 12-month late acquired stent malapposition (LASM)
- One-month LM Synergy stent safety
- 1-, 3- and 12-month MACE
- 1-, 3- and 12-month Stent Thrombosis (ST) (ARC definition) 75 patients undergoing LM PCI (protected or unprotected) with Boston Scientific Synergy™ stent.
The goal is to enroll 75 patients from up to 10 VA sites and an enrollment period of 3 years, each site is expected to include 7-10 patients during the study period.
After a total of 75 patients are enrolled the study will be closed for further enrollment.
Eligible patients will be screened at each participating center and those who had undergone LM PCI with Boston Scientific Synergy™ stent and where OCT was performed during the index procedure will be eligible. The index procedure may be performed by any interventional cardiologist - this is specifically needed in order to maintain equipoise on the part of stent choice and use of OCT.
At the end of the study enrollment period, the proportion of patients at each site treated with Synergy stents vs. non-Synergy stents and the proportion of patients that underwent OCT imaging during LM PCI will be collected.
Eligible patients will be approached and consented for inclusion in the SOLEMN trial after the initial procedure.
Study Duration
Patients will be followed for 12 months after the index procedure. At one month, clinical follow-up will be performed (clinic or telephone). At 3 months, the angiography and OCT will be performed. At 12 months, the final angiography and OCT will be performed. No further follow-up is planned after completion of the 3- and 12-month angiography and OCT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography | Other | Device: Optical Coherence TomographyPatients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or greater;
- Left Main CAD, defined as ≥ 50% diameter stenosis and amenable to re-vascularization by PCI;
- Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- Ability to comply with minimum of 6 months of DAPT after the index procedure.
- Unprotected Left Main PCI
Key exclusion criteria (15 listed)
- Coexisting conditions that limit life expectancy to less than 12 months or that could affect patient's compliance with the protocol;
- Serum creatinine greater than 2.0 mg/dL;
- Cardiogenic shock;
- STEMI;
- Non-STEMI, if the cardiac troponin is not stable or starting to decline;
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 |
|---|---|---|
| Optical Coherence TomographyAlso: Dragonfly OPTIS Imaging CatheterOCT will be performed with the St. Jude OCT system. Detection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium. | Device | Optical Coherence Tomography |
Primary outcome
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
Time frame: 3 Months
The stents from 6 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.
4 secondary outcomes
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
Time frame: 12 month
3-month Persistent Stent Malapposition
Time frame: 3 month
12-month Persistent Stent Malapposition
Time frame: 12 month
Major Adverse Cardiac Event (MACE)
Time frame: MACE reported at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mladen I Vidovich, MD principal investigator
Jesse Brown VA Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with Percutaneous Coronary Intervention and Optical Coherence Tomography, run by Jesse Brown VA Medical Center at 13 sites 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 15 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 17 May 2024). 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?
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI) (time frame: 3 Months). 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 17 May 2024.