Bare Metal BifuRcAtion SteNt Clinical Trial in Humans (IP088) With Coronary Stenosis At or Near a Vessel Bifurcation - Safety at 30-Days

Bare Metal Bifurcation Stent Clinical Trial in Humans (IP088) - Safety at 30 Days

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000072314

Acronym

BRANCH

Enrollment

Registered

2008-02-08

Start date

2008-02-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A prospective multi-center, non-randomized, single arm trial enrolling up to 60 patients with symptomatic ischemic heart disease attributable to a bifurcation lesion that is amenable to percutaneous treatment with stenting. A bifurcation lesion must have =/> 50% stenosis in the main branch. Trial patients may have multiple vessel disease but only a single bifurcation lesion per patient mmay be treated during the trial procedure, with no other lesions of any type treated at this time-point. Clinical follow-up assessment will be performed at 30-days post procedure. Patient contact for follow-up assesment will be performed at 6 months, 9 months and 12 months post-procedure

Interventions

Angiographic placement of a bare metal coronary stent in a lesion at or near a vessel bifurcation. Stent intended for permanent placement (endothelialization into vessel wall)

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient is =/> 18 years old Acceptable candidate for Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG) Clinical evidence of ischemic heart disease Female patients with negative pregnancy test Informed Consent Obtained Agrees to comply with follow-up evaluations Single de novo bifurcation lesion in a native coronary artery with specific dimensions Stenosis =/> 50% and < 100% Thrombolysis in Myocardial Infarction (TIMI) flow =/> 2

Exclusion criteria

Hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 WBC < 3,000 cells/mm3 Serum creatinine level > 170 micromol/L Evidence of MI within 72 hours of intended trial procedure Previous stenting in Target Vessel LVEF < 30% History of stroke or TIA within 6 months History of bleeding diathesis or coagulopathy or refusal of blood transfusion Specific target lesion morphology

Outcome results