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

NCT ID: NCT02607241

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-10-31

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).

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).

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

OCT-guided BRS implantation

Intervention Type: DEVICE

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

DCB-only

FFR-guided DCB-only PCI: PCI using DCB (SeQuent Please™, B Braun Melsungen GmBH) without stent implantation und FFR guidance

Group Type: EXPERIMENTAL

FFR-guided DCB-only PCI

Intervention Type: DEVICE

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).

Interventions

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

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KKS Netzwerk

NETWORK

Sponsor Role: collaborator

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Tudor C. Poerner, MD

PD Dr. med. Tudor C. Poerner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tudor C Poerner, MD

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital

Locations

University Hospital of Jena, Heart Center, Division of Cardiology

Jena, , Germany

Countries

Germany

Other Identifiers

UKJ-TCP-3

Identifier Type: -

Identifier Source: org_study_id