The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study (DOCTOR Recross)

October 5, 2015 updated by: Niels Ramsing Holm, Aarhus University Hospital Skejby

Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (OCT) guided vs. angiography guided wire recrossing in jailed side branches (SB) (1. randomization 1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and 30 days clinical follow-up.

Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the SB ostium.

Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime stent.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Purpose:

To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.

To compare stent strut apposition after treatment by two different stent designs using both guiding strategies of wire recrossing.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:
          • Tom Adriaenssens, MD
        • Principal Investigator:
          • Tom Adriasenssens, MD
  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hspital
        • Contact:
        • Contact:
          • Evald H Christiansen, MD
          • Phone Number: 52028 +45 7845 0000
          • Email: hellbarg@rm.dk
        • Principal Investigator:
          • Niels R Holm, MD
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Brompton Hospital
        • Contact:
          • Carlo DiMario, MD
        • Principal Investigator:
          • Carlo DiMario, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable or unstable angina pectoris or silent angina pectoris.
  • De novo coronary bifurcation lesions at "LAD/diagonal", "Cx/obtuse marginal", "right coronary artery (RCA)- posterior descending artery (PDA)/posterolateral branch" or "left main (LM)/Cx/LAD".
  • All Medina classes except Medina 0.0.1.
  • Diameter of side branch ≥2.5 mm.
  • Diameter stenosis >50% by operator's visual assessment
  • Signed informed consent

Exclusion Criteria:

  • ST-elevation infarction within 48 hours.
  • Side branch lesion length >5 mm.
  • Expected survival < 1 year
  • Severe heart failure (NYHA≥III)
  • S-creatinine >120 µmol/l.
  • Allergy to Contrast media, Aspirin, Clopidogrel, Ticagrelor, Ticlopidine, Everolimus or Zotarolimus.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medtronic Resolute Integrity stent
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Procedure: Angiography
Other Names:
  • CAG
Procedure: OCT
Experimental: OCT
OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Device: Xience Prime Stent
Other Names:
  • Stent
Device: Medtronic Resolute Integrity stent
Other Names:
  • Stent
Active Comparator: Angiography
Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Device: Xience Prime Stent
Other Names:
  • Stent
Device: Medtronic Resolute Integrity stent
Other Names:
  • Stent
Active Comparator: Xience Prime stent
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Procedure: Angiography
Other Names:
  • CAG
Procedure: OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cross sectional stent strut malapposition in the main vessel bifurcation segment facing the side-branch ostium compared for optical coherence tomography and angioguided recrossing strategy
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
Time Frame: Baseline
Baseline
Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
Time Frame: Baseline
Baseline
Procedural: 3. Contrast use
Time Frame: Baseline
Baseline
Procedural: 4. Fluoroscopy time
Time Frame: Baseline
Baseline
Optical coherence tomography endpoints: 5. Malapposition in the main vessel segment limited by and facing the side-branch ostium compared for stent type (second randomization)
Time Frame: Baseline
Baseline
Optical coherence tomography endpoints: Malapposition in the proximal and distal main vessel segments and in the quadrants opposite to the side branch origin for stent type and recross strategy
Time Frame: Baseline
Baseline
Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
Time Frame: Baseline
Baseline
Optical coherence tomography endpoints: Minimum expansion of the stents expressed as absolute area and percentage of the closest reference area, for stent type and recross strategy
Time Frame: Baseline
Baseline
Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
Time Frame: Baseline
Baseline
Angiographic endpoints: Segmental assessment; Proximal edge, proximal main vessel, bifurcation segment, distal main vessel, distal edge, ostial 5 mm of side branch. Pre and post side branch intervention
Time Frame: Baseline
Baseline
Ostial side branch area stenosis
Time Frame: Baseline
Baseline
Ostial side branch acute gain after main vessel (MV) stenting
Time Frame: Baseline
Baseline
Minimal luminal area of all segments
Time Frame: Baseline
Baseline
Angiographic area stenosis of all other segments
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Aarhus University Hospital Skejby

Collaborators

Medtronic
Abbott Medical Devices

Investigators

  • Principal Investigator: Niels R Holm, MD, Aarhus University Hospital Skejby

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

July 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-111-13

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.

Clinical Trials on Coronary Disease

Clinical Trials on Angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe