SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI (SOLEMN)
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|ClinicalTrials.gov Identifier: NCT03474432|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Percutaneous Coronary Intervention Optical Coherence Tomography In-stent Coronary Artery Restenosis||Device: Optical Coherence Tomography||Not Applicable|
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.
• 3-month stent strut coverage in LM PCI
- 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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI|
|Estimated Study Start Date :||April 15, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Optical Coherence Tomography
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.
Device: Optical Coherence Tomography
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.
Other Name: Dragonfly OPTIS Imaging Catheter
- Stent strut coverage in LM PCI [ Time Frame: 3 Months ]The stent strut coverage 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.
- 12-month stent strut coverage in LM PCI [ Time Frame: 12 month ]The stent strut coverage 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.
- Late Acquired Stent Malapposition (LASM) [ Time Frame: 3 and 12 months ]Malapposition will be defined as a measured distance greater than the total thickness of the stent metal plus polymer of the stent.
- Major Adverse Cardiac Event (MACE) [ Time Frame: 1, 3 and 12 months ]
- Myocardial infarction
- Stroke (cerebrovascular accident or CVA)
- Urgent revascularization
- Repeat revascularization
- Stent thrombosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474432
|Contact: Mladen I Vidovich, MDfirstname.lastname@example.org|
|Contact: Decebal Griza, MD||312-569-6129||Decebal.Griza@va.gov|
|United States, Alabama|
|Birmingham VA Medical Center|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Southern Arizona VA Health Care System|
|Tucson, Arizona, United States, 85723|
|United States, California|
|VA Long Beach Healthcare|
|Long Beach, California, United States, 90822|
|San Francisco VA|
|San Francisco, California, United States, 94121|
|United States, Colorado|
|VA Eastern Colorado Health Care System|
|Denver, Colorado, United States, 80220|
|United States, Georgia|
|Atlanta VA Medical Center|
|Atlanta, Georgia, United States, 30033|
|United States, Ohio|
|VA Louis Stokes Cleveland VA Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Oklahoma|
|Oklahoma City VA Health Care System|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System|
|Pittsburgh, Pennsylvania, United States, 15240|
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center|
|Charleston, South Carolina, United States, 29401|
|United States, Texas|
|Dallas VA Medical Center|
|Dallas, Texas, United States, 75216|
|San Antonio VA|
|San Antonio, Texas, United States, 78028|
|Principal Investigator:||Mladen I Vidovich, MD||Jesse Brown VA Medical Center|