Fact CheckerSign in

NCT02973529Active, not recruiting

The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study

Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
22 Nov 2016
Start date
Jan 2016
Primary completion date
Nov 2026
Lead sponsor
Aarhus University Hospital Skejby
NCT number
NCT02973529

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From Jan 2016 to the primary completion date, Nov 2026
  • 4 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe heart failure (NYHA≥III)
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus

Lab values

  • S-creatinine \> 120 µmol/L

Other

  • ST-elevation infarction within 48 hours
  • Expected survival \< 1 year
  • Unable to cover main vessel lesion with one scaffold
  • Severe tortuosity
  • Severe calcification

Who the study is looking for

  • Stable angina pectoris
  • Age \> 18 years
  • Stabilized non-ST elevation myocardial infarction
  • Silent angina
  • De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch
  • All Medina classes except Medina x.x.1
  • Diameter of side branch ≥ 2.5 mm
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus University Hospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkUnknown status
Odense University Hospital
Coordinator of this site? Confirm its status
OdenseDenmarkUnknown status
Zealand University Hospital, Roskilde
Coordinator of this site? Confirm its status
RoskildeDenmarkUnknown status
Latvian Heart Center
Coordinator of this site? Confirm its status
RigaLatviaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.