search
Back to results

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

Primary Purpose

Coronary Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Xience Prime Stent
Medtronic Resolute Integrity stent
Angiography
OCT
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary angiography (CAG), Percutaneous coronary intervention (PCI), OCT, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals LeuvenRecruiting
  • Aarhus University HspitalRecruiting
  • Royal Brompton HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Medtronic Resolute Integrity stent

OCT

Angiography

Xience Prime stent

Arm Description

Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium

OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.

Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.

Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
Procedural: 3. Contrast use
Procedural: 4. Fluoroscopy time
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)
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
Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
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
Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
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
Ostial side branch area stenosis
Ostial side branch acute gain after main vessel (MV) stenting
Minimal luminal area of all segments
Angiographic area stenosis of all other segments

Full Information

First Posted
June 5, 2014
Last Updated
October 5, 2015
Sponsor
Aarhus University Hospital Skejby
Collaborators
Abbott Medical Devices, Medtronic
search

1. Study Identification

Unique Protocol Identification Number
NCT02234804
Brief Title
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Acronym
DOCTOR Recross
Official Title
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Abbott Medical Devices, Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary angiography (CAG), Percutaneous coronary intervention (PCI), OCT, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medtronic Resolute Integrity stent
Arm Type
Experimental
Arm Description
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Arm Title
OCT
Arm Type
Experimental
Arm Description
OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Arm Title
Angiography
Arm Type
Active Comparator
Arm Description
Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Arm Title
Xience Prime stent
Arm Type
Active Comparator
Arm Description
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Intervention Type
Device
Intervention Name(s)
Xience Prime Stent
Other Intervention Name(s)
Stent
Intervention Type
Device
Intervention Name(s)
Medtronic Resolute Integrity stent
Other Intervention Name(s)
Stent
Intervention Type
Procedure
Intervention Name(s)
Angiography
Other Intervention Name(s)
CAG
Intervention Type
Procedure
Intervention Name(s)
OCT
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
Time Frame
Baseline
Title
Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
Time Frame
Baseline
Title
Procedural: 3. Contrast use
Time Frame
Baseline
Title
Procedural: 4. Fluoroscopy time
Time Frame
Baseline
Title
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
Title
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
Title
Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
Time Frame
Baseline
Title
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
Title
Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
Time Frame
Baseline
Title
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
Title
Ostial side branch area stenosis
Time Frame
Baseline
Title
Ostial side branch acute gain after main vessel (MV) stenting
Time Frame
Baseline
Title
Minimal luminal area of all segments
Time Frame
Baseline
Title
Angiographic area stenosis of all other segments
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niels R Holm, MD
Phone
+45 7845 0000
Ext
52254
Email
niels.holm@ki.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Evald H Christiansen, MD
Phone
+45 7845 0000
Ext
52028
Email
hellbarg@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels R Holm, MD
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Adriaenssens, MD
First Name & Middle Initial & Last Name & Degree
Tom Adriasenssens, MD
Facility Name
Aarhus University Hspital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels R Holm, MD
Phone
+45 7845 0000
Ext
52254
Email
niels.holm@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Evald H Christiansen, MD
Phone
+45 7845 0000
Ext
52028
Email
hellbarg@rm.dk
First Name & Middle Initial & Last Name & Degree
Niels R Holm, MD
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo DiMario, MD
First Name & Middle Initial & Last Name & Degree
Carlo DiMario, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs