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

Coronary Disease Clinical Trial

— DOCTOR Recross  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02234804
• Other study ID #: 1-10-72-111-13
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2014
• Last updated: October 5, 2015
• Start date: July 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2015
• Source: Aarhus University Hospital Skejby
• Contact: Niels R Holm, MD
• Phone: +45 7845 0000
• Email: niels.holm[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Xience Prime Stent

• Medtronic Resolute Integrity stent

Procedure:
• Angiography

• OCT

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Denmark	Aarhus University Hspital	Aarhus N
United Kingdom	Royal Brompton Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Medtronic, St. Jude Medical

Countries where clinical trial is conducted

Belgium,  Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline	No
Secondary	Procedural: 1. Success in recrossing into designated strut hole when visible and indicated		Baseline	No
Secondary	Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)		Baseline	No
Secondary	Procedural: 3. Contrast use		Baseline	No
Secondary	Procedural: 4. Fluoroscopy time		Baseline	No
Secondary	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)		Baseline	No
Secondary	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		Baseline	No
Secondary	Optical coherence tomography endpoints: Distance between malapposed strut and vessel wall in all segments for stent type and recross strategy		Baseline	No
Secondary	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		Baseline	No
Secondary	Optical coherence tomography endpoints: Ostial stent area stenosis by optical coherence tomography (side branch reference area by 3D QCA)		Baseline	No
Secondary	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		Baseline	No
Secondary	Ostial side branch area stenosis		Baseline	No
Secondary	Ostial side branch acute gain after main vessel (MV) stenting		Baseline	No
Secondary	Minimal luminal area of all segments		Baseline	No
Secondary	Angiographic area stenosis of all other segments		Baseline	No