Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study

NCT ID: NCT02776267

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-06-30

Brief Summary

The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).

Detailed Description

This is a prospective registry including patient scheduled for a clinically-indicated percutaneous coronary intervention (PCI) of a de novo epicardial lesion with indication for drug-eluting stent implantation. Following study enrolment and PCI/stent with the Angiolite DES, patients will be scheduled for follow-up surveillance coronary angiography and OCT with the C7-XRTM Fourier Domain OCT system with C7 DragonflyTM catheter (St Jude Medical, Minneapolis, MN) or with the Terumo LunawayTM OCT system with fastview catheter (Terumo Medical Corporation, Tokyo, Japan). An adaptive design component of the study will randomize patients to either 3-month or 6-month angio/OCT follow-up. Clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post PCI.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angiolite stent - 3-month angiogram/OCT

Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 3-month post index PCI.

Group Type: EXPERIMENTAL

Angiolite stent

Intervention Type: DEVICE

Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.

Angiolite stent - 6-month angiogram/OCT

Patients scheduled for PCI (and whot meet pre-specified inlcusion criteria) are enrolled to receive the Angiolite DES. They will undergo a scheduled repeat coronary angiogram and OCT evaluation at 6-month post index PCI.

Group Type: EXPERIMENTAL

Angiolite stent

Intervention Type: DEVICE

Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.

Interventions

Angiolite stent

Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.

Intervention Type: DEVICE

Other Intervention Names

(Angiolite CE Mark reference number: 2014 12 0833 ED)

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for clinically-indicated PCI of a de nove epicardial lesion, including those with chronic stable angina, ACS (defined as NSTEMI or ACS with negative cardiac enzymes) or in the setting of elective PCI.
• Indication for DES implantation
• Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia
• Strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up
• Target lesion, if possible, should be predilated/pretreated

Exclusion Criteria

• Age >85 years
• Acute ST segment elevation MI (STEMI)
• Cardiogenic shock
• Known left ventricular ejection fraction <30%
• Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration
• Iodinated contrast allergy
• Renal impairment with serum creatinine >2.0 mg/dL
• Anticipated medical non-compliance
• Life-expectancy <12 months
• Chronic total occlusion (CTO) in the target vessel
• Bifurcation lesion requiring a two-stent strategy
• In-stent restenosis
• Severe lesion/segment angulation/tortuosity
• Severe vessel/lesion calcification
• Simultaneous PCI within the same or different vessel during the same procedure
• Lesion unsuitable for OCT (proximal lesions <10 mm from ostium of left main or right coronary arteries)
• Lesion length >18 mm
• Stent length >24 mm
• Stent diameter ≤2.5 mm and > 4.0 mm
• Unprotected left main coronary artery disease (≥50% diameter stenosis)
• >1 lesion
• Planned use of 2 overlapping stents

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iVascular

UNKNOWN

Sponsor Role: collaborator

Josep Rodes-Cabau

OTHER

Sponsor Role: lead

Responsible Party

Josep Rodes-Cabau

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Josep Rodes-Cabau, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

Hospital Vall D'Hebron

Barcelona, , Spain

Hospital Universitario de Leon

León, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Countries

Spain

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Other Identifiers

ANCHOR

Identifier Type: -

Identifier Source: org_study_id