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

Primary Purpose

Stable Angina, Coronary Stenosis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
FFR - guided DEB angioplasty
Provisional bare metal stenting
Sponsored by
University of Jena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring PCI, Drug-eluting balloon (DEB), Fractional flow reserve (FFR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

FFR - guided DEB angioplasty

DEB angioplasty with provisional bare metal stenting

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
April 19, 2014
Last Updated
April 20, 2014
Sponsor
University of Jena
Collaborators
B. Braun Melsungen AG
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1. Study Identification

Unique Protocol Identification Number
NCT02120859
Brief Title
Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty
Acronym
OCTOPUS-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Coronary Stenosis
Keywords
PCI, Drug-eluting balloon (DEB), Fractional flow reserve (FFR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FFR - guided DEB angioplasty
Arm Type
Experimental
Arm Description
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.
Arm Title
DEB angioplasty with provisional bare metal stenting
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FFR - guided DEB angioplasty
Other Intervention Name(s)
Sequent Please® paclitaxel-eluting balloon (DEB)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Provisional bare metal stenting
Other Intervention Name(s)
Coroflex Blue® bare metal stent (BMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Late lumen loss
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Vessel remodeling assessed by optical coherence tomography
Description
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
Time Frame
6 months
Title
Net lumen gain
Description
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
Time Frame
6 months
Title
Need for revascularization of the treated vessel segment
Description
Need for revascularization of the treated vessel segment (target lesion revascularization, TLR) driven either clinically or after 6-month angiographic follow-up
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Cardiac death or acute myocardial infarction due to target vessel failure
Description
Cardiac death or acute myocardial infarction occurring in the presence of occlusion or severe flow limitation of the treated vessel
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tudor C Poerner, MD
Organizational Affiliation
University Hospital of Jena, Heart Center, Cardiology Division
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans R Figulla, MD
Organizational Affiliation
University Hospital of Jena, Heart Center, Cardiology Divisio
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Jena, Heart Center, Division of Cardiology
City
Jena
ZIP/Postal Code
07747
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27379610
Citation
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.
Results Reference
derived

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

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