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Coronary Artery DiseaseBIFSORBNCT02973529

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

A study testing Absorb and Desolve in people with Coronary Artery Disease, run by Aarhus University Hospital Skejby at 4 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Absorb and Desolve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesin 2 countries
Study dates
Jan 2016to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • ST-elevation infarction within 48 hours
  • Expected survival < 1 year
  • Severe heart failure (NYHA≥III)
  • S-creatinine > 120 µmol/L
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus
  • Unable to cover main vessel lesion with one scaffold
  • Severe tortuosity
  • Severe calcification

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Denmark3 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Odense University Hospital

    Odense

  • Zealand University Hospital, Roskilde

    Roskilde

Other trials in Denmark

Latvia1 site

  • Latvian Heart Center

    Riga

Other trials in Latvia

About this study

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

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.

Read the detailed description

BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions.

BRS are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

The aim of this study is to compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS.

Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS.

Methods:

Prospective, open label, single blind, randomized, feasibility and safety pilot study with inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month follow-up by OCT and follow-up for clinical endpoints until 10 years.

Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the BRS.

The patients are assessed by optical coherence tomography (OCT) before, during and after implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month follow-up, or before if they are readmitted with a possible target lesion failure.

The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before performing final OCT.

Results are reported as clinical safety at 6 months (myocardial infarction, revascularization, death) and stent healing index by OCT including malapposition, stent coverage, side branch ostial area late loss, fracture and evaginations.

Being tested
Absorb, Desolve
Keywords
Percutaneous intervention (PCI), Optical coherence tomography (OCT), Bifurcation lesion, Bioresorbable stents (BRS)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbsorbDevice

    Randomization to implantation of Absorb BVS in bifurcation lesion

  • DesolveDevice

    Randomization to implantation of Desolve BRS in bifurcation lesion

Study groups in NCT02973529
Study groupRoleWhat they receive
AbsorbExperimentalRandomization to implantation of Absorb BVS in bifurcation lesion
Receives: Device: Absorb
DesolveExperimentalRandomization to implantation of Desolve BRS in bifurcation lesion
Receives: Device: Desolve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.

    Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.

    Measured: 6 months

  2. Index of adverse vessel wall features

    Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain

    Measured: 6 months

Secondary outcomes (34)

  1. Optical coherence tomography endpoint: acute malapposition

    Measured: Baseline

  2. Optical coherence tomography endpoint: acquired malapposition

    Measured: 6 and 24 months

  3. Optical coherence tomography endpoint: persistent malapposition

    Measured: 6 and 24 months

  4. Optical coherence tomography endpoint: Coverage of jailing struts

    Measured: 6 and 24 months

  5. Optical coherence tomography endpoint: Extra stent lumen (including evaginations)

    Measured: Baseline, 6 and 24 months

  6. Optical coherence tomography endpoint: Late stent recoil

    Measured: 6 and 24 months

  7. Optical coherence tomography endpoint: stent fracture

    Measured: Baseline, 6 and 24 months

  8. Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts

    Measured: Baseline, 6 and 24 months

  9. Optical coherence tomography endpoint: Ostial strut loss

    Measured: Baseline, 6 and 24 months

  10. Optical coherence tomography endpoint: Mean neointimal thickness

    Measured: 6 and 24 months

  11. Optical coherence tomography endpoint: Stent strut coverage

    Measured: 6 and 24 months

  12. Optical coherence tomography endpoint: Minimal luminal area in segmental analysis

    Measured: Baseline, 6 and 24 months

  13. Optical coherence tomography endpoint: Minimal stent area in segmental analysis

    Measured: Baseline, 6 and 24 months

  14. Optical coherence tomography endpoint: Minimum scaffold expansion area %

    Measured: Baseline, 6 and 24 months

  15. Optical coherence tomography endpoint: Segmental area stenosis

    Measured: Baseline, 6 and 24 months

  16. Optical coherence tomography endpoint: Healing above calcified plaque

    Measured: 6 and 24 months

  17. Optical coherence tomography endpoint: Healing above lipid plaque

    Measured: 6 and 24 months

  18. Optical coherence tomography endpoint: Acute thrombus on struts

    Measured: Baseline

  19. Optical coherence tomography endpoint: Late thrombus on struts

    Measured: 6 and 24 months

  20. Optical coherence tomography endpoint: Acute expansion

    Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation

    Measured: Baseline

  21. Optical coherence tomography endpoint:Late recoil

    Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation

    Measured: 6 and 24 months

  22. Angiographic endpoint: Ostial side branch area stenosis

    Measured: Baseline, 6 and 24 months

  23. Angiographic endpoint: Ostial side branch acute gain after main vessel stenting

    Measured: Baseline

  24. Angiographic endpoint: Ostial side branch late loss

    Measured: 6 and 24 months

  25. Angiographic endpoint: Ostial distal main vessel area stenosis

    Measured: Baseline, 6 and 24 months

  26. Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting

    Measured: Baseline

  27. Angiographic endpoint: Ostial distal main vessel late loss

    Measured: 6 and 24 months

  28. Angiographic endpoint: Proximal main vessel area stenosis

    Measured: Baseline, 6 and 24 months

  29. Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting

    Measured: Baseline

  30. Angiographic endpoint: Proximal main vessel late loss

    Measured: 6 and 24 months

  31. Angiographic endpoint: Minimal luminal area of all segments

    Measured: Baseline, 6 and 24 months

  32. Procedural endpoints: Procedure time

    From sheath insertion to closure device excluding treatment of other vessels

    Measured: Baseline

  33. Procedural endpoints: Contrast use

    Measured: Baseline

  34. Procedural endpoints: Fluoroscopy time

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionNov 2026 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973529
Sponsor's protocol ID
1-10-72-215-14
Acronym
BIFSORB
Status last verified
Dec 2025
First submitted
22 Nov 2016
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Absorb and Desolve in people with Coronary Artery Disease, run by Aarhus University Hospital Skejby at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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