Clinical trial NCT03106961: OCT and Scaffold Embedding After NC Balloon
Official title: An Optical Coherence Tomography Evaluation of the Effects of High-Pressure, Non-compliant Ballooning on Scaffold Embedding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
Collaborators: name: Akiko Maehara, MD
First posted: 2017-04-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the percentage of the number of embedded scaffold struts as evaluated by OCT
timeFrame: intra-procedure (PCI)
Secondary outcomes:
measure: Change in minimum scaffold cross-sectional area
timeFrame: intra-procedure (PCI)
measure: Change in mean scaffold cross-sectional area
timeFrame: intra-procedure (PCI)
measure: Change in the ratio of minimum scaffold cross-sectional area and expected scaffold cross-sectional area from manufacturer chart of balloon
timeFrame: intra-procedure (PCI)
measure: Change in the ratio of minimum scaffold cross-sectional area and average of proximal and distal reference lumen cross-sectional
timeFrame: intra-procedure (PCI)
measure: Change in the Percentage of footprint
timeFrame: intra-procedure (PCI)
measure: Comparison of scaffold embedding between non-calcified plaque and moderate calcified plaque (arc <180°)
timeFrame: intra-procedure (PCI)
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
Study officials:
affiliation: St FrancisHospiral
name: Richard A Shlofmitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Scalone G, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Munzel T, Lee CH, Cequier A, Valdes M, Widimsky P, Serruys PW, Sabate M. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):189-197. doi: 10.1016/j.jcin.2014.10.005.
citation: Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
citation: Cassese S, Byrne RA, Ndrepepa G, Kufner S, Wiebe J, Repp J, Schunkert H, Fusaro M, Kimura T, Kastrati A. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet. 2016 Feb 6;387(10018):537-544. doi: 10.1016/S0140-6736(15)00979-4. Epub 2015 Nov 17.
citation: Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016 Mar 1;67(8):921-931. doi: 10.1016/j.jacc.2015.12.019.