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

Phase 4

Completed

• Conditions: Stable Angina; Coronary Stenosis
• Interventions: Device: FFR - guided DEB angioplasty; Device: Provisional bare metal stenting

• Registration Number: NCT02120859
• Lead Sponsor: University of Jena

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).

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-12
• Status Verified: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-04-19
• Study First Submitted QC: 2014-04-20
• Last Update Submitted: 2014-04-20
• Study First Posted: 2014-04-23
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FFR - guided DEB angioplasty	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.
DEB angioplasty with provisional bare metal stenting	FFR - guided DEB angioplasty	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.
DEB angioplasty with provisional bare metal stenting	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.

Primary Outcome Measures

Name	Time	Method
Late lumen loss	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Jena, Heart Center, Division of Cardiology; 🇩🇪 Jena, Germany