OCT and Scaffold Embedding After NC Balloon

• Conditions: Coronary Artery Disease

• Registration Number: NCT03106961
• Lead Sponsor: St. Francis Hospital, New York

Brief Summary

This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions.

Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.

Detailed Description

This study is a single-center, prospective, observational study designed to enroll 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.

Eligible subjects who meet inclusion and exclusion criteria for BVS scaffold implant will have a BVS-specific implantation protocol with high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. Because the scaffold is compliant, a perfectly embedded scaffold is sometimes observed in a lesion with soft plaque, resulting in a smaller intra-luminal scaffold volume that may reduce the event rate. Enrolled subjects will have OCT ( optical coherence tomography ) pre and post BVS implantation to assess the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation (using the moderate pressure of 12 atm) to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-04
• Study Start: 2017-03-30
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-11
• Last Update Posted: 2017-04-11
• Primary Completion: 2018-03-22
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients ≥18 years who undergo PCI of de novo lesions in the setting of stable angina or acute coronary syndromes.
2. The culprit lesion must be successfully pre-dilated prior to enrollment. -

Exclusion Criteria

I. Patient specific

1. Cardiogenic shock (sustained [>10 min] systolic blood pressure <90 mm Hg in absence of inotropic support or the presence of an intra-aortic balloon pump support).
2. Known severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.72 m2).
3. Intolerance of aspirin or thienopyridines
4. ST-segment elevation myocardial infarction
5. Subject is a woman of childbearing potential, pregnant, or nursing.
6. Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
7. Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, ticagrelor or prasugrel, or to everolimus, PLLA polymers, or contrast sensitivity that cannot be adequately pre-medicated.
8. Subject has a platelet count <100,000 cell/mm3 or >700,000 cell/mm3, a white blood cell count of <3,000 cell/mm3, or documented or suspected liver disease in the recent blood test.

II. Lesion specific

1. Left main disease defined as diameter stenosis >50%
2. Ostial lesion
3. Tortuous artery in which OCT is unable to pass
4. Lesion in a bypass graft
5. Reference vessel diameter (RVD) <2.5 mm or >4 mm
6. Bifurcation lesions with side branches >2 mm
7. In-stent restenosis
8. Previous placement of a stent proximal or distal to or within 10 mm of the target lesion
9. Chronic total occlusion
10. Lesions with calcified plaque >180° by pre-intervention OCT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the percentage of the number of embedded scaffold struts as evaluated by OCT	intra-procedure (PCI)	Percentage of embedded scaffold strut is defined as the ratio of the number of embedded strut to the total number of analyzed strut per lesion. (% of embedded scaffold struts = No. of embedded struts / total No. of analyzed struts) The analysis will be done for both OCT images 1) after initial bioresorbable scaffold implantation using moderate pressure and 2) after post-dilatation using high pressure non-compliant balloon, and the change in percentage of embedded scaffold strut from initial bioresorbable scaffold implantation to post-dilation will be calculated. (∆ % of embedded scaffold struts = % of embedded scaffold struts of initial scaffold implantation - % of embedded scaffold struts of post-dilatation)

Secondary Outcome Measures

Name	Time	Method
Change in minimum scaffold cross-sectional area	intra-procedure (PCI)	Minimum scaffold cross-sectional area defined as the smallest endoluminal area within the entire scaffold cross-section. We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Change in the ratio of minimum scaffold cross-sectional area and average of proximal and distal reference lumen cross-sectional	intra-procedure (PCI)	We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Change in the Percentage of footprint	intra-procedure (PCI)	Percentage of footprint defined as the ratio of outer BVS scaffold surface area to total luminal surface area. We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Change in mean scaffold cross-sectional area	intra-procedure (PCI)	Mean scaffold cross-sectional area defined as the average of endoluminal area within the entire scaffold cross-section. We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Change in the ratio of minimum scaffold cross-sectional area and expected scaffold cross-sectional area from manufacturer chart of balloon	intra-procedure (PCI)	We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon.
Comparison of scaffold embedding between non-calcified plaque and moderate calcified plaque (arc <180°)	intra-procedure (PCI)	In the strut level, the percentage of embedded scaffold struts between calcified plaque and non-calcified plaque will be compared. And about the lesion, Other secondary endpoints(2-7) listed above will be compared between calcified plaque and non-calcified plaque will be compared.

Trial Locations

Locations (1)

St Francis Hospital; 🇺🇸 Roslyn, New York, United States