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

NCT02234804 | Unknown DMC

• 1 other identifier: 1-10-72-111-13
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

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.

Conditions

Coronary Disease

Keywords

Coronary angiography (CAG); Percutaneous coronary intervention (PCI); OCT; Stent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Procedural: 1. Success in recrossing into designated strut hole when visible and indicated

  Baseline

• Procedural: 2. Procedure duration (sheath insertion to closure device excluding treatment of other vessels)

  Baseline

• Procedural: 3. Contrast use

  Baseline

• Procedural: 4. Fluoroscopy time

  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)

  Baseline

Study Arms (4)

Medtronic Resolute Integrity stent

EXPERIMENTAL

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

Procedure: Angiography; Procedure: OCT

OCT

EXPERIMENTAL

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

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.

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

Procedure: Angiography; Procedure: OCT

Interventions

Xience Prime Stent DEVICE

Also known as: Stent

Angiography; OCT

Medtronic Resolute Integrity stent DEVICE

Also known as: Stent

Angiography; OCT

Angiography PROCEDURE

Also known as: CAG

Medtronic Resolute Integrity stent; Xience Prime stent

OCT PROCEDURE

Medtronic Resolute Integrity stent; Xience Prime stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Abbott Medical Devices: collaborator
• Medtronic: collaborator

Study Sites (3)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Aarhus University Hspital

Aarhus N, 8200, Denmark

RECRUITING

Royal Brompton Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Interventions

Stents; Cerebral Angiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Niels R Holm, MD

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels R Holm, MD

CONTACT

+45 7845 0000; niels.holm@ki.au.dk

Evald H Christiansen, MD

CONTACT

+45 7845 0000; hellbarg@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: September 9, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

BE (1); GB (1); DK (1)