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

July 16, 2018 updated by: Josep Rodes-Cabau

Percutaneous Coronary Intervention With the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study. The ANCHOR Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Leon, Spain
        • Hospital Universitario de Leon
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Santander, Spain
        • Hospital Universitario Marques de Valdecilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: 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.
Other Names:
  • (Angiolite CE Mark reference number: 2014 12 0833 ED)
EXPERIMENTAL: 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.
Device: 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.
Other Names:
  • (Angiolite CE Mark reference number: 2014 12 0833 ED)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neo-intimal coverage
Time Frame: 6-month

Strut-based analysis: % of covered struts. Cross-sectional analysis: number of cross-sections with RUTTS (Rate of uncovered to total number of struts) score>30%.

Measured by an independant OCT laboratory
6-month
Neo-intimal obstruction
Time Frame: 6-month
Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neo-intimal coverage
Time Frame: 3-month

Strut-based analysis: % of covered struts. Cross-sectional analysis: number of cross-sections with RUTTS (Rate of uncovered to total number of struts) score>30%.

Measured by an independant OCT laboratory.
3-month
Neo-intimal obstruction
Time Frame: 3-month
Strut-based analysis: mean neointimal thickness (µm). Cross-sectional analysis: neointimal volume obstruction (%). Measured by an independant OCT laboratory.
3-month
Apposition
Time Frame: 3- and 6-month
Strut-based analysis: incomplete strut apposition (ISA) rate. Cross-sectional analysis: % frames with ISA. Measured by an independant OCT laboratory.
3- and 6-month
In-stent angiographic late lumen in mm
Time Frame: 6-month
Confirmed by Imaging and measured by an independant QCA laboratory
6-month
In-stent and in-segment restenosis
Time Frame: 6-month
Confirmed by Imaging and measured by an independant QCA laboratory (Reduction in percent diameter stenosis of stented segment of >= 50%
6-month
CV death
Time Frame: 6-month and 1-year
Death from any known cardiovascular etiology
6-month and 1-year
Myocardial infarction
Time Frame: Peri-procedural, spontaneous
Peri-procedural myocardial infarction will be defined according to the 3rd universal definition of MI Following PCI, myocardial infarction will be defined according to the specific clinical situation of the patient.
Peri-procedural, spontaneous
Target-lesion revascularization
Time Frame: 24 months
Any repeat revascularization du to a restenosis within the DES-treated segment
24 months
Binary restenosis
Time Frame: 24 months
Reduction in percent diameter stenosis of stented segment of < vs.>= 50%
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josep Rodes-Cabau

Collaborators

iVascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

February 7, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (ESTIMATE)

May 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCHOR (Other Identifier: AIDS Malignancy Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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