OCT and Scaffold Embedding After NC Balloon

NCT03106961 | Unknown

• 1 other identifier: 16-19
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change in the percentage of the number of embedded scaffold struts as evaluated by OCT

  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)

  intra-procedure (PCI)

Secondary Outcomes (6)

• Change in minimum scaffold cross-sectional area

  intra-procedure (PCI)

• Change in mean scaffold cross-sectional area

  intra-procedure (PCI)

• Change in the ratio of minimum scaffold cross-sectional area and expected scaffold cross-sectional area from manufacturer chart of balloon

  intra-procedure (PCI)

• Change in the ratio of minimum scaffold cross-sectional area and average of proximal and distal reference lumen cross-sectional

  intra-procedure (PCI)

• Change in the Percentage of footprint

  intra-procedure (PCI)

Interventions

Bioresorbable vascular scaffolds, OCT, non-compliant ballooning DEVICE

Measure the effect of high-pressure, NC ballooning on scaffold embedding by OCT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• I. Patient specific
• 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).
• Known severe renal insufficiency (estimated glomerular filtration rate \<30 mL/min/1.72 m2).
• Intolerance of aspirin or thienopyridines
• ST-segment elevation myocardial infarction
• Subject is a woman of childbearing potential, pregnant, or nursing.
• Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
• 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.
• 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
• Left main disease defined as diameter stenosis \>50%
• Ostial lesion
• Tortuous artery in which OCT is unable to pass
• Lesion in a bypass graft
• Reference vessel diameter (RVD) \<2.5 mm or \>4 mm

Sponsors & Collaborators

• St. Francis Hospital, New York: lead
• Akiko Maehara, MD: collaborator

Study Sites (1)

St Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Related Publications (5)

• Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Munzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015 Feb;10(10):1144-53. doi: 10.4244/EIJY14M07_11.

  PMID: 25042421 BACKGROUND

• 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.

  PMID: 25616924 BACKGROUND

• 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.

  PMID: 26825231 BACKGROUND

• 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.

  PMID: 26597771 BACKGROUND

• 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.

  PMID: 26916481 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Richard A Shlofmitz, MD

  St FrancisHospiral

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricahrd A Shlofmitz, MD

CONTACT

516 390-9640; richard.shlofmitz@chsli.org

Elizabeth S Haag, RN

CONTACT

516 562-6790; elizabeth.haag@chsli.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Cardiology

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: April 11, 2017
• Study Start: March 30, 2017
• Primary Completion: March 22, 2018
• Study Completion: June 30, 2018
• Last Updated: April 11, 2017

Record last verified: 2016-10

Locations

US (1)