Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty (OCTOPUS-2)

April 20, 2014 updated by: Tudor C. Poerner, MD, University of Jena

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07747
        • University Hospital of Jena, Heart Center, Division of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FFR - guided DEB angioplasty
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.
Device: FFR - guided DEB angioplasty
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.
Other Names:
  • Sequent Please® paclitaxel-eluting balloon (DEB)
OTHER: DEB angioplasty with provisional bare metal stenting
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.
Device: FFR - guided DEB angioplasty
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.
Other Names:
  • Sequent Please® paclitaxel-eluting balloon (DEB)
Device: Provisional bare metal stenting
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.
Other Names:
  • Coroflex Blue® bare metal stent (BMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late lumen loss
Time Frame: 6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel remodeling assessed by optical coherence tomography
Time Frame: 6 months
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
6 months
Net lumen gain
Time Frame: 6 months
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
6 months
Need for revascularization of the treated vessel segment
Time Frame: 6 months
Need for revascularization of the treated vessel segment (target lesion revascularization, TLR) driven either clinically or after 6-month angiographic follow-up
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death or acute myocardial infarction due to target vessel failure
Time Frame: 6 month
Cardiac death or acute myocardial infarction occurring in the presence of occlusion or severe flow limitation of the treated vessel
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

B. Braun Melsungen AG

Investigators

  • Study Director: Tudor C Poerner, MD, University Hospital of Jena, Heart Center, Cardiology Division
  • Study Chair: Hans R Figulla, MD, University Hospital of Jena, Heart Center, Cardiology Divisio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

April 19, 2014

First Submitted That Met QC Criteria

April 20, 2014

First Posted (ESTIMATE)

April 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 20, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKJ-TCP-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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