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

NCT ID: NCT02120859

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-04-30

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).

Conditions

Stable Angina; Coronary Stenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FFR - guided DEB angioplasty

Intervention Type: DEVICE

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.

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.

Group Type: OTHER

FFR - guided DEB angioplasty

Intervention Type: DEVICE

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 stenting

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Sequent Please® paclitaxel-eluting balloon (DEB); Coroflex Blue® bare metal stent (BMS)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Tudor C. Poerner, MD

PD Dr. med. Tudor C. Poerner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tudor C Poerner, MD

Role: STUDY_DIRECTOR

University Hospital of Jena, Heart Center, Cardiology Division

Hans R Figulla, MD

Role: STUDY_CHAIR

University Hospital of Jena, Heart Center, Cardiology Divisio

Locations

University Hospital of Jena, Heart Center, Division of Cardiology

Jena, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 27379610 (View on PubMed)

Other Identifiers

UKJ-TCP-2

Identifier Type: -

Identifier Source: org_study_id