Bare Metal Bifurcation Stent Clinical Trial in Humans

NCT00607321 | Completed Results DMC

• 1 other identifier: IP088
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the feasibility and safety of the Medtronic Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of 3.0 - 3.5 mm, and side branch RVD up to 2.5 mm.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Keywords

restenosis; Coronary Disease; Coronary Arteriosclerosis; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.

  TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.

  30 days

Secondary Outcomes (4)

• Device Success

  During index procedure

• Number of Participants With Target Vessel Failure (TVF) at 6 Months

  6 month

• Number of Participants With Target Vessel Failure at 9 Months.

  9 month

• Number of Participant With Target Vessel Failure at 12 Months

  12 month

Study Arms (1)

1

EXPERIMENTAL

Medtronic Bifurcation Stent System

Device: Medtronic Bifurcation Stent System

Interventions

Medtronic Bifurcation Stent System DEVICE

Percutaneous Coronary Stenting

1

Eligibility Criteria

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

You may qualify if:

• Candidate for percutaneous coronary intervention \& emergent coronary artery bypass graft surgery
• Clinical evidence of ischemic heart disease or a positive functional study
• Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
• Patient or patient's legal representative provided written informed consent
• Patient agrees to comply with follow-up evaluations
• Target lesion ia a single de novo bifurcation lesion involving a native coronary artery with reference vessel diameter for the proximal main of 3.8 - 4.3 mm, distal main of 3.0 - 3.5 mm, \& side branch RVD up to 2.5 mm
• Acceptable target lesion lengths are any combination of:
• \<16mm proximally from carina in proximal main vessel
• \<16mm distally from the carina in distal main branch
• \<12mm from carina in side branch
• Target lesion in main vessel has stenosis of \> 50% and \<100%
• Target vessel has (TIMI) flow \>2

You may not qualify if:

• Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
• Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or a white blood cell (WBC) count \<3,000 cells/mm³ within 7 days prior to index procedure
• Serum creatinine level \>170 micromol/L within 7 days prior to index procedure
• Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes \>2X laboratory upper limit of normal with presence of elevated CK-MB (any amount above laboratory upper limit of normal)
• Previous stenting anywhere in target vessel
• PCI of non-target vessel within 30 days prior to procedure that results in any MACE event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal.
• PCI of non-target vessel within 24 hours prior to procedure
• Planned PCI of any vessel within 30 days post-procedure
• Planned PCI of the target vessel within 6 months post-procedure
• During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
• Documented left ventricular ejection fraction (LVEF) \<30% at most recent evaluation.
• History of stroke or transient ischemic attack (TIA) within prior 6 months
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Concurrent medical condition with life expectancy \< 12 months

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Results Point of Contact

• Title: K Bogdanovich
• Organization: Medtronic Cardiovascular

rs.medtroniccardiovascularclinicaltrials@medtronic.com

Study Officials

• Ian Meredith, MD

  Monash Medical Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 18, 2017
• Results First Posted: August 31, 2011

Record last verified: 2017-04

Locations

NZ (1)