Coronary DiseaseDOCTOR RecrossNCT02234804
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
A study testing Xience Prime Stent, Medtronic Resolute Integrity stent and Angiography in people with Coronary Disease, run by Aarhus University Hospital Skejby at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Xience Prime Stent, Medtronic Resolute Integrity stent and Angiography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2013to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Tom Adriaenssens, MD
Tom Adriasenssens, MD
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hspital
Aarhus N, 8200
Niels R Holm, MD, +45 7845 0000 ext. 52254, niels.holm@clin.au.dk
Evald H Christiansen, MD, +45 7845 0000 ext. 52028, hellbarg@rm.dk
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London
Carlo DiMario, MD
Carlo DiMario, MD
About this study
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.
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Xience Prime Stent, Medtronic Resolute Integrity stent, Angiography, OCT
- Keywords
- Coronary angiography (CAG), Percutaneous coronary intervention (PCI), OCT, Stent
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xience Prime StentDevice
Also called Stent
Medtronic Resolute Integrity stentDevice
Also called Stent
AngiographyProcedure or surgery
Also called CAG
OCTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Resolute Integrity stent | Experimental | Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium Receives: Procedure: Angiography; Procedure: OCT |
| OCT | Experimental | OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. Receives: Device: Xience Prime Stent; Device: Medtronic Resolute Integrity stent |
| Angiography | Active comparator | Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. Receives: Device: Xience Prime Stent; Device: Medtronic Resolute Integrity stent |
| Xience Prime stent | Active comparator | Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium Receives: Procedure: Angiography; Procedure: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (14)
Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
Measured: Baseline
Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
Measured: Baseline
Procedural: 3. Contrast use
Measured: Baseline
Procedural: 4. Fluoroscopy time
Measured: 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)
Measured: 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
Measured: Baseline
Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
Measured: 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
Measured: Baseline
Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
Measured: 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
Measured: Baseline
Ostial side branch area stenosis
Measured: Baseline
Ostial side branch acute gain after main vessel (MV) stenting
Measured: Baseline
Minimal luminal area of all segments
Measured: Baseline
Angiographic area stenosis of all other segments
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Medtronic
- Responsible party
- Principal investigator, Niels Ramsing Holm, Aarhus University Hospital Skejby
- Investigators
- Niels R Holm, MD, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234804
- Sponsor's protocol ID
- 1-10-72-111-13
- Acronym
- DOCTOR Recross
- Status last verified
- Oct 2015
- First submitted
- 5 Jun 2014
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
- ClinicalTrials.gov ID
- NCT02234804
- Acronym / sponsor ID
- DOCTOR Recross / 1-10-72-111-13
- Conditions
- Coronary Disease
- Keywords
- Coronary angiography (CAG), Percutaneous coronary intervention (PCI), OCT, Stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Medtronic
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medtronic Resolute Integrity stent | Experimental | Procedure: Angiography, Procedure: OCTComparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium |
| OCT | Experimental | Device: Xience Prime Stent, Device: Medtronic Resolute Integrity stentOCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. |
| Angiography | Active comparator | Device: Xience Prime Stent, Device: Medtronic Resolute Integrity stentAngiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. |
| Xience Prime stent | Active comparator | Procedure: Angiography, Procedure: OCTComparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xience Prime StentAlso: Stent | Device | Angiography, OCT |
| Medtronic Resolute Integrity stentAlso: Stent | Device | Angiography, OCT |
| AngiographyAlso: CAG | Procedure or surgery | Medtronic Resolute Integrity stent, Xience Prime stent |
| OCT | Procedure or surgery | Medtronic Resolute Integrity stent, Xience Prime stent |
Primary outcome
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
14 secondary outcomes
Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
Time frame: Baseline
Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
Time frame: Baseline
Procedural: 3. Contrast use
Time frame: Baseline
Procedural: 4. Fluoroscopy time
Time frame: 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
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
Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
Time frame: 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
Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
Time frame: 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
Ostial side branch area stenosis
Time frame: Baseline
Ostial side branch acute gain after main vessel (MV) stenting
Time frame: Baseline
Minimal luminal area of all segments
Time frame: Baseline
Angiographic area stenosis of all other segments
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels R Holm, MD principal investigator
Aarhus University Hospital Skejby
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xience Prime Stent, Medtronic Resolute Integrity stent and Angiography in people with Coronary Disease, run by Aarhus University Hospital Skejby at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niels R Holm, MD (+45 7845 0000 ext. 52254, niels.holm@ki.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.