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Completed

NCT Number: NCT02120859

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Jena, Heart Center, Division of Cardiology

Jena, 07747, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Sequent Please® paclitaxel-eluting balloon (DEB)

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.

Other names: Coroflex Blue® bare metal stent (BMS)

Primary outcomes

  1. Late lumen loss

    Time frame: 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 outcomes

  1. Vessel remodeling assessed by optical coherence tomography

    Time frame: 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

  2. Net lumen gain

    Time frame: 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

  3. Need for revascularization of the treated vessel segment

    Time frame: 6 months

    Need for revascularization of the treated vessel segment (target lesion revascularization, TLR) driven either clinically or after 6-month angiographic follow-up

Other outcomes

  1. Cardiac death or acute myocardial infarction due to target vessel failure

    Time frame: 6 month

    Cardiac death or acute myocardial infarction occurring in the presence of occlusion or severe flow limitation of the treated vessel

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Official study 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

Acronym: OCTOPUS-2

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 23, 2014
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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