Trial Outcomes & Findings for SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI (NCT NCT03474432)

Last Updated: 2024-05-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

3 Months

Results posted on

2024-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	12
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optical Coherence Tomography n=12 Participants 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. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: 6 participants had stents analyzed at 3 months.

Outcome measures

Outcome measures
Measure	Optical Coherence Tomography n=6 Stents 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. 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.
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)	93.8 Percentage of Uncovered Stent Struts Interval 86.3 to 95.0

SECONDARY outcome

Timeframe: 12 month

Population: 2 participants had data analyzed at 12 months.

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.

Outcome measures

Outcome measures
Measure	Optical Coherence Tomography n=2 Stents 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. 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.
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)	94.7 Percentage of Uncovered Stent Struts Interval 93.6 to 95.7

SECONDARY outcome

Timeframe: 3 month

Population: Number of participants with persistent stent malapposition at 3 months

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.

Outcome measures

Outcome measures
Measure	Optical Coherence Tomography n=6 Participants 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. 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.
3-month Persistent Stent Malapposition	4 Participants

SECONDARY outcome

Timeframe: 12 month

Population: Participants with data analyzed at 12 months. 1 out of 2 participants analyzed had malapposition at 12-month.

Outcome measures

Outcome measures
Measure	Optical Coherence Tomography n=2 Participants 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. 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.
12-month Persistent Stent Malapposition	1 Participants

SECONDARY outcome

Timeframe: MACE reported at 12 months

Population: Participants with MACE reported at 12 months.

MACE include: * Death * Myocardial infarction * Stroke (cerebrovascular accident or CVA) * Urgent revascularization * Repeat revascularization * Bleeding * Stent thrombosis * Rehospitalization

Outcome measures

Outcome measures
Measure	Optical Coherence Tomography n=12 Participants 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. 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.
Major Adverse Cardiac Event (MACE)	1 Participants

Adverse Events

Optical Coherence Tomography

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Optical Coherence Tomography n=12 participants at risk 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. 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.
Renal and urinary disorders Urinary Tract infection	8.3% 1/12 • Number of events 1 • Adverse events were collected at 1, 3, 6 and 12 months.
Cardiac disorders Stent mallaposition needing angioplasty	8.3% 1/12 • Number of events 1 • Adverse events were collected at 1, 3, 6 and 12 months.

Other adverse events

Other adverse events
Measure	Optical Coherence Tomography n=12 participants at risk 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. 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.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	8.3% 1/12 • Number of events 1 • Adverse events were collected at 1, 3, 6 and 12 months.

Additional Information

Dr. Mladen Vidovich, study PI

Jesse Brown VAMC

Phone: 312-996-6730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place