Trial Outcomes & Findings for Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels (NCT NCT02098876)

NCT ID: NCT02098876

Last Updated: 2022-09-09

Results Overview

Cross-sectional area in neointimal hyperplasia by Optical Coherence Tomography (OCT) at 1 year following stent placement

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-09-09

Participant Flow

Participants were recruited from 12 SITES. Participant enrollment began in May 2014 and all follow up was complete by December 2020.

Participant milestones

Measure	Resolute Integrity DES Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Overall Study STARTED	45	41
Overall Study COMPLETED	40	36
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Resolute Integrity DES Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Overall Study Withdrawal by Subject	5	5

Baseline Characteristics

Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels

Baseline characteristics by cohort

Measure	Resolute Integrity DES n=45 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=41 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 11.6 • n=5 Participants	63.8 years STANDARD_DEVIATION 10.6 • n=7 Participants	63.2 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment South Korea	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment Latvia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment China	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Japan	8 participants n=5 Participants	12 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Serbia	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Spain	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The numbers for each different endpoint are dependent on the data quality and availability for each endpoint.

Cross-sectional area in neointimal hyperplasia by Optical Coherence Tomography (OCT) at 1 year following stent placement

Outcome measures

Measure	Resolute Integrity DES n=32 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=35 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage	1.381 mm^2 Standard Deviation 1.026	0.949 mm^2 Standard Deviation 0.767

SECONDARY outcome

Timeframe: 1 year

Mean thickness of strut coverage at follow up (In-Stent safety endpoint). Struts have been considered as covered when tissue overlying the struts is >0 μm by optical coherence tomography (OCT)

Outcome measures

Measure	Resolute Integrity DES n=32 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=35 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
In Stent: Mean Thickness of Strut Coverage at Follow up	0.118 mm^2 Standard Deviation 0.109	0.096 mm^2 Standard Deviation 0.09

SECONDARY outcome

Timeframe: Immediately after stent implantation

post PCI angulation by Angio: In-Stent: Degree of vascular straightening post-percutaneous coronary intervention (PCI) (In-Stent mechanistic endpoint)

Outcome measures

Measure	Resolute Integrity DES n=42 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=40 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint)	40 Degree Standard Deviation 25	36 Degree Standard Deviation 33

SECONDARY outcome

Timeframe: Immediately after stent implantation

Plaque will be identified by Optical Coherence Tomography (OCT)- In-Stent: Plaque prolapse post-PCI (In-Stent mechanistic endpoint)

Outcome measures

Measure	Resolute Integrity DES n=39 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=38 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
In Stent: Plaque Prolapse Post-PCI (In-Stent Mechanistic Endpoint)	0.12 mm^2 Standard Deviation 0.14	0.13 mm^2 Standard Deviation 0.16

SECONDARY outcome

Timeframe: Immediately after stent implantation

Population: This outcome required that patients received computational fluid dynamics analysis, unfortunately, this was not possible in all patients.

The % area of low wall shear stress immediately after stent implantation will be measured by Optical Coherence Tomography (OCT)

Outcome measures

Measure	Resolute Integrity DES n=41 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=37 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint)	0.9 percentage of area Standard Deviation 0.13	0.9 percentage of area Standard Deviation 0.11

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants with images that are of adequate quality for analysis. The number reported corresponds to the actual change in plaque area between baseline and 1 year follow-up

Change in plaque area at the stent edges will be calculated from the change in plaque area in the 5 mm proximal and distal segments by intravascular ultrasound (IVUS); calculated as follow-up values minus baseline values

Outcome measures

Measure	Resolute Integrity DES n=34 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=31 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent.	-0.8 mm^2 Standard Deviation 1.7	-0.5 mm^2 Standard Deviation 2.8

SECONDARY outcome

Timeframe: Immediately after stent implantation

Population: This outcome only requires baseline angiograms hence more patients meet this criteria.

Degree of vascular straightening post-percutaneous coronary intervention (PCI) at the stent edges (Stent Edge mechanistic endpoint) will be measured post PCI angulation by Angio

Outcome measures

Measure	Resolute Integrity DES n=42 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=40 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Stent Edge: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) at the Stent Edges (Stent Edge Mechanistic Endpoint)	22 Degrees Standard Deviation 14	21 Degrees Standard Deviation 14

SECONDARY outcome

Timeframe: Immediately after stent implantation

Population: This outcome required that patients received computational fluid dynamics analysis, unfortunately, this was not possible in all patients.

The % area of low wall shear stress in the 5 mm proximal and distal segments immediately after stent implantation will be measured by intravascular ultrasound (IVUS).

Outcome measures

Measure	Resolute Integrity DES n=41 Participants Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=37 Participants Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Stent Edge: Percent Area With Low Wall Shear Stress (WSS) at Stent Edges Post-PCI (Mechanistic Endpoint)	0.6 percentage of area Standard Deviation 0.23	0.64 percentage of area Standard Deviation 0.29

Adverse Events

Resolute Integrity DES

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Xience Xpedition DES

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Resolute Integrity DES n=45 participants at risk Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=41 participants at risk Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Cardiac disorders Recurrent Chest Pain	2.2% 1/45 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	0.00% 0/41 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).
Gastrointestinal disorders Appendectomy	0.00% 0/45 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	2.4% 1/41 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).
Cardiac disorders Balloon Fracture	2.2% 1/45 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	0.00% 0/41 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).
Cardiac disorders Pericardial Effusion	0.00% 0/45 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	2.4% 1/41 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).

Other adverse events

Measure	Resolute Integrity DES n=45 participants at risk Resolute Integrity zotarolimus eluting stent Resolute Integrity Zotarolimus eluting stent: PCI with Resolute stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.	Xience Xpedition DES n=41 participants at risk Xience Xpedition everolimus eluting stent Xience Xpedition everolimus eluting stent: PCI with Xience stent Optical Coherence Tomography (OCT): Optical coherence tomography (OCT) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. OCT will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area and stent area will be performed for each OCT cross-section from baseline and follow up examinations. Intravascular Ultrasound (IVUS): Intravascular ultrasound (IVUS) will be performed at baseline to assess plaque burden prior to and after stent deployment as well as to evaluate stent expansion and stent apposition. IVUS will be repeated at one year follow-up to evaluate neo-intimal tissue coverage within the stent and change in plaque area at the stent edges. Offline, manual detection of lumen area, stent area, vessel area (external elastic membrane) and the media-adventitia interface will be performed for each IVUS cross-section from baseline and follow up examinations.
Cardiac disorders Unstable Angina	0.00% 0/45 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	2.4% 1/41 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).
Surgical and medical procedures Target vessel revascularization	0.00% 0/45 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	2.4% 1/41 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).
Cardiac disorders Chest pain	0.00% 0/45 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).	2.4% 1/41 • Number of events 1 • All patients were followed while in hospital for major adverse events (starting 12-24Hr post-procedure, up to 1- year).

Additional Information

Habib Samady

Northeast Georgia Health System

Phone: 770-297-3549

Email: Habib.Samady@nghs.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place