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Stable AnginaPhase 4OCTOPUS-2NCT02120859

Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty

A Phase 4 study testing FFR - guided DEB angioplasty and Provisional bare metal stenting in people with Stable Angina and Coronary Stenosis, run by University of Jena at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stable Angina, Coronary Stenosis
What is being tested?
FFR - guided DEB angioplasty and Provisional bare metal stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
Oct 2012to Apr 2014
Phase
Phase 4
Are there results?
None posted in the registry

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

  • Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology
  • Age > 18 years, written consent
  • Native de novo coronary lesion suitable for angioplasty and OCT imaging

Who cannot join

  • Pregnancy and breast feeding mother
  • Co-morbidity with an estimated life expectancy of < 50 % at 1 year
  • Scheduled major surgery in the next 6 months
  • Not able to give informed written consent or non-compliance
  • Participation in other PCI trial
  • Acute coronary syndromes and cardiogenic shock
Show all 10Show fewer
  • Known allergy to aspirin, thienopyridines or against taxol derivates
  • Culprit lesion within the proximal 10 mm of the right or left coronary artery
  • Saphenous vein grafts
  • Estimated lesion length > 30 mm

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital of Jena, Heart Center, Division of Cardiology

    Jena, 07747

Other trials in Germany

About this study

Official title: Fractional Flow Reserve - Guided Elective Coronary Angioplasty Using Paclitaxel - Eluting Balloons With Provisional Stent Implantation: A Phase 4 Feasibility Study With 6-Month Follow-up by Optical Coherence Tomography

We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.

Read the detailed description

Restenosis rates after plain-old balloon angioplasty (POBA) are with 30-50 % very high. Therefore, this interventional concept is of limited use today. However, dual antiplatelet therapy (DAPT) is not necessary after POBA. Contrary, 3rd generation drug-eluting stents (DES) proved to be very effective showing delayed restenosis only in 5-15%, but require DAPT for at least 6 months. Drug-eluting balloons (DEB) might be a promising trade-off between POBA and DES, since they effectively inhibit neointimal proliferation despite minimal duration of DAPT. However, there is still very limited data on this interventional strategy. Thus, we aimed to investigate feasibility of fractional flow reserve (FFR) - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (OCT).

Being tested
FFR - guided DEB angioplasty, Provisional bare metal stenting
Keywords
PCI, Drug-eluting balloon (DEB), Fractional flow reserve (FFR)
Medical subject headings
Angina, Stable, Coronary Stenosis

What participants receive

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

  • FFR - guided DEB angioplastyDevice

    Also called Sequent Please® paclitaxel-eluting balloon (DEB)

    DEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis < 40% and FFR > 0.8.

  • Provisional bare metal stentingDevice

    Also called Coroflex Blue® bare metal stent (BMS)

    In case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.

Study groups in NCT02120859
Study groupRoleWhat they receive
FFR - guided DEB angioplastyExperimentalDEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis < 40% and FFR > 0.8.
Receives: Device: FFR - guided DEB angioplasty
DEB angioplasty with provisional bare metal stentingOtherIn case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.
Receives: Device: FFR - guided DEB angioplasty; Device: Provisional bare metal stenting

What is being measured

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

  1. Late lumen loss

    Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 6-month follow-up

    Measured: 6 months

Secondary outcomes (3)

  1. Vessel remodeling assessed by optical coherence tomography

    Lumen and vessel measurements, neointimal proliferation, plaque composition and dissection healing within the treated vessel segment at 6 months assessed by optical coherence tomography (OCT) with 3D-reconstruction

    Measured: 6 months

  2. Net lumen gain

    Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 6-month follow-up and MLD at the lesion site at baseline

    Measured: 6 months

  3. Need for revascularization of the treated vessel segment

    Need for revascularization of the treated vessel segment (target lesion revascularization, TLR) driven either clinically or after 6-month angiographic follow-up

    Measured: 6 months

Timeline

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

  1. First posted23 Apr 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2013
  4. Study completionApr 2014

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120859
Sponsor's protocol ID
UKJ-TCP-2
Acronym
OCTOPUS-2
Status last verified
Apr 2014
First submitted
19 Apr 2014
Last updated
23 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Poerner TC, Duderstadt C, Goebel B, Kretzschmar D, Figulla HR, Otto S. Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol. 2017 Jan;106(1):18-27. doi: 10.1007/s00392-016-1019-4. Epub 2016 Jul 5.

    PubMed 27379610

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FFR - guided DEB angioplasty and Provisional bare metal stenting in people with Stable Angina and Coronary Stenosis, run by University of Jena at 1 site in Germany.

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 3 inclusion and 10 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: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Late lumen loss (time frame: 6 months). 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 NCT02120859, which also lists 1 linked publication.

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 23 Apr 2014; AzTrials last refreshed its copy on 1 Nov 2026.

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