OCT and Scaffold Embedding After NC Balloon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bioresorbable vascular scaffolds, OCT, non-compliant ballooning

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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No