Clinical trial NCT02120859: Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina
Coronary Stenosis
Keywords: PCI
Drug-eluting balloon (DEB)
Fractional flow reserve (FFR)
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
First posted: 2014-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Late lumen loss
timeFrame: 6 months
Secondary outcomes:
measure: Vessel remodeling assessed by optical coherence tomography
timeFrame: 6 months
measure: Net lumen gain
timeFrame: 6 months
measure: Need for revascularization of the treated vessel segment
timeFrame: 6 months
Other outcomes:
measure: Cardiac death or acute myocardial infarction due to target vessel failure
timeFrame: 6 month
Locations:
city: Jena
country: Germany
facility: University Hospital of Jena, Heart Center, Division of Cardiology
Study officials:
affiliation: University Hospital of Jena, Heart Center, Cardiology Division
name: Tudor C Poerner, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Jena, Heart Center, Cardiology Divisio
name: Hans R Figulla, MD
role: STUDY_CHAIR
References:
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.