Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT03474432
Status:
TERMINATED
Last Update Posted:
2024-05-17
First Post:
2018-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Sponsor:
Jesse Brown VA Medical Center
Organization:
Study Overview
Official Title:
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLEMN
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: