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

Coronary Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120859
• Other study ID #: UKJ-TCP-2
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2014
• Last updated: April 20, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Stenosis
• Stable Angina

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital of Jena, Heart Center, Division of Cardiology	Jena

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac death or acute myocardial infarction due to target vessel failure	Cardiac death or acute myocardial infarction occurring in the presence of occlusion or severe flow limitation of the treated vessel	6 month	Yes
Primary	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	6 months	No
Secondary	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	6 months	No
Secondary	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	6 months	No
Secondary	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	6 months	No