NCT02607241

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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).

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-02-01
• Completion: 2018-10-01
• First posted: 2015-11-18
• Last updated: 2018-10-26

Locations

1 site across 1 country: Germany