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

NCT02120859 | Completed Phase 4 DMC

• 1 other identifier: UKJ-TCP-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Coronary Stenosis

Keywords

PCI; Drug-eluting balloon (DEB); Fractional flow reserve (FFR)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Vessel remodeling assessed by optical coherence tomography

  6 months

• Net lumen gain

  6 months

• Need for revascularization of the treated vessel segment

  6 months

Other Outcomes (1)

• Cardiac death or acute myocardial infarction due to target vessel failure

  6 month

Study Arms (2)

FFR - guided DEB angioplasty

EXPERIMENTAL

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.

Device: FFR - guided DEB angioplasty

DEB angioplasty with provisional bare metal stenting

OTHER

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.

Device: FFR - guided DEB angioplasty; Device: Provisional bare metal stenting

Interventions

FFR - guided DEB angioplasty 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.

Also known as: Sequent Please® paclitaxel-eluting balloon (DEB)

DEB angioplasty with provisional bare metal stenting; FFR - guided DEB angioplasty

Provisional bare metal stenting 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.

Also known as: Coroflex Blue® bare metal stent (BMS)

DEB angioplasty with provisional bare metal stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead
• B. Braun Melsungen AG: collaborator

Study Sites (1)

University Hospital of Jena, Heart Center, Division of Cardiology

Jena, 07747, Germany

Location

Related Publications (1)

• 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.

  PMID: 27379610 DERIVED

MeSH Terms

Conditions

Angina, Stable; Coronary Stenosis

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease

Study Officials

• Tudor C Poerner, MD

  University Hospital of Jena, Heart Center, Cardiology Division

  STUDY DIRECTOR

• Hans R Figulla, MD

  University Hospital of Jena, Heart Center, Cardiology Divisio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Tudor C. Poerner

Study Record Dates

• First Submitted: April 19, 2014
• First Posted: April 23, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

DE (1)