Clinical trial NCT02234804: The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Official title: The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary angiography (CAG)
Percutaneous coronary intervention (PCI)
OCT
Stent
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Medtronic
First posted: 2014-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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
timeFrame: Baseline
Secondary outcomes:
measure: Procedural: 1. Success in recrossing into designated strut hole when visible and indicated
timeFrame: Baseline
measure: Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)
timeFrame: Baseline
measure: Procedural: 3. Contrast use
timeFrame: Baseline
measure: Procedural: 4. Fluoroscopy time
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Ostial side branch area stenosis
timeFrame: Baseline
measure: Ostial side branch acute gain after main vessel (MV) stenting
timeFrame: Baseline
measure: Minimal luminal area of all segments
timeFrame: Baseline
measure: Angiographic area stenosis of all other segments
timeFrame: Baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Aarhus N
country: Denmark
facility: Aarhus University Hspital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Niels R Holm, MD
role: PRINCIPAL_INVESTIGATOR
References: