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Comparison of Paclitaxel-Coated Balloons Against Drug-Eluting Bioresorbable Scaffolds for Elective PCI Using OCT (OCTOPUS-3)

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ClinicalTrials.gov Identifier: NCT02607241
Recruitment Status : Terminated (The product used in the comparator arm (BRS) has become unavailable in April 2017. The recruitment has been stopped.)
First Posted : November 18, 2015
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
KKS Netzwerk
Information provided by (Responsible Party):
Tudor C. Poerner, MD, University of Jena

Brief Summary:
This prospective randomized clinical trial aims to compare two different "metal-free" strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: OCT-guided BRS implantation Device: FFR-guided DCB-only PCI Phase 4

Detailed Description:

Background:

Coronary artery disease (CAD) accounts for most deaths in the industrialized countries due to its high prevalence of 6-8%. CAD is mainly treated by percutaneous coronary interventions (PCI), which currently involve in over 90% of cases the implantation of metallic stents, mostly as drug-eluting devices(DES). Despite continuous technological advancement over the last decade, DES are still limited at long-term follow-up by restenosis and also by the risk of thrombosis, occurring in 5-20% and respectively 0.5-1.7% of cases. Therefore, two metal-free strategies are evaluated in order to overcome these intrinsic limitations of DES:

  1. Bioresorbable scaffolds (BRS) proved comparable safety and efficacy at 1 year compared to best-in-class DES comparators and also showed in small substudies very promising 5-year results with restoration of vasomotricity and positive vessel remodeling. Optical coherence tomography (OCT) is the new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. OCT is currently recommended for both guidance of implantation and for assessment of long-term results of BRS.
  2. Drug-coated balloons (DCB) were mainly employed to treat restenosis in metallic stents, but newer reports advocate their potential to be used as stand-alone treatment of de-novo stenoses without stenting, especially when fractional flow reserve (FFR) measurements are additionally used to assess PCI results.

This clinical trial evaluates the FFR-guided DCB-only (experimental arm: SeQuent Please™, B Braun Melsungen GmBH) PCI against the OCT-guided BRS implantation (comparator arm: Absorb™, Abbott Vascular) for treatment of stable CAD. The trial is designed as a non-inferiority, nationally conducted, multicenter, open-labeled, controlled study using a 1:1 block randomization and am invasive 6-9 month follow-up (f/u) by quantitative coronary angiography (QCA) and OCT.

Beyond the pre-specified endpoints the study mainly looking at suppression of neointimal proliferation, we will also investigate the patterns of healing and neointimal proliferation, the plaque morphology and neoatherosclerosis f/u using OCT at 6-9 months. Clinically, we attempt to record the major adverse cardiovascular events (MACE: acute myocardial infarction, cardiac death, TLR) up to 5 years after the index procedure.

A number of 196 patients scheduled for PCI with a native coronary stenosis suitable for BRS implantation and OCT imaging will be openly 1:1 randomized. This number of patients is considered to be sufficient to prove non-inferiority of DCB-only vs. BRS, using a margin of 0.2 mm with a confidence interval of 0.5 mm for the primary endpoint (diameter NLG).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of a Paclitaxel-Coated Balloon Without Stent Implantation Against a Drug-Eluting Bioresorbable Scaffold for Treatment of Stable Coronary Artery Disease: A Prospective Randomized Study Using Optical Coherence Tomography
Study Start Date : November 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: BRS

OCT-guided BRS implantation: implantation of a bioresorbable scaffold (BRS) under OCT guidance.

Note: Absorb™ from Abbott Vascular has been used as BRS until this product became unavailable in April 2017. Currently the recruitment is stopped due to this issue, until the use of another BRS gets final approval.

Device: OCT-guided BRS implantation
Implantation of a BRS using OCT to measure vessel size, choose BRS size and length and assess implantation results and the need of further postdilations

Experimental: DCB-only
FFR-guided DCB-only PCI: PCI using DCB (SeQuent Please™, B Braun Melsungen GmBH) without stent implantation und FFR guidance
Device: FFR-guided DCB-only PCI
PCI performed under FFR guidance using following algorithm: (1) predilation followed by angiographic assessment of residual stenosis and dissections; (2) evaluate suitability for DCB-only, which is deemed feasible if the FFR > 0.8, residual diameter stenosis < 40% and no flow-limiting dissections are observed; (3) DCB dilation and (4) assessment of final results using FFR and QCA measurements. Provisional stenting is allowed only if the final PCI results are not acceptable (flow-limiting dissection, residual stenosis > 40% or FFR < 0.8).




Primary Outcome Measures :
  1. Angiographic NLG [ Time Frame: 6-9 months ]
    Absolute net luminal diameter gain measured by QCA as minimal luminal diameter at f/u - minimal luminal diameter at baseline within the region of interest


Secondary Outcome Measures :
  1. Volumetric NLG [ Time Frame: 6-9 months ]
    Absolute net luminal volumetric gain using three-dimensional OCT-based vessel segment reconstruction at f/u

  2. Angiographic and volumetric LLL [ Time Frame: 6-9 months ]
    Absolute late luminal diameter loss (LLL) using QCA and late luminal volumetric loss by OCT at f/u

  3. TLR [ Time Frame: 0-9 months ]
    % clinically driven target lesion revascularization (TLR) during f/u


Other Outcome Measures:
  1. Acute TVF [ Time Frame: 0-9 months ]
    Target vessel failure requiring emergent revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written consent
  • indication for elective PCI of a de novo coronary stenosis in a native vessel
  • coronary multivessel disease with clinically proven indication for repeating coronary angiography at 6-9 months (staged PCI strategy)

Exclusion Criteria:

  • pregnancy, lactation, women of childbearing age w/o reliable contraception
  • life expectance < 50 % at 1 year
  • major surgery planned within 6 months
  • participation in other clinical trials or impossibility to give written consent
  • acute coronary syndrome or cardiogenic shock within the last 4 weeks
  • stent thrombosis, defined as "probable" or "definite" by ARC
  • contraindication against dual antiplatelet therapy
  • allergy against mTOR-inhibitors or taxol derivates
  • target lesion situated in the left main coronary artery, in a bypass graft or a grafted vessel
  • reference luminal diameter of the target lesion > 3.75 mm or < 2.0 mm
  • lesion length > 30 mm, bifurcation lesion requiring intervention on a major side branch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607241


Locations
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Germany
University Hospital of Jena, Heart Center, Division of Cardiology
Jena, Germany, 07747
Sponsors and Collaborators
University of Jena
KKS Netzwerk
Investigators
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Principal Investigator: Tudor C Poerner, MD Universitätsklinikum Jena

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Responsible Party: Tudor C. Poerner, MD, PD Dr. med. Tudor C. Poerner, University of Jena
ClinicalTrials.gov Identifier: NCT02607241     History of Changes
Other Study ID Numbers: UKJ-TCP-3
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Keywords provided by Tudor C. Poerner, MD, University of Jena:
drug-coated balloon
bioresorbable scaffold
fractional flow reserve
optical coherence tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action