Clinical trial NCT02607241: Comparison of Paclitaxel-Coated Balloons Against Drug-Eluting Bioresorbable Scaffolds for Elective PCI Using OCT
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: drug-coated balloon
bioresorbable scaffold
fractional flow reserve
optical coherence tomography
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: KKS Netzwerk
First posted: 2015-11-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Angiographic NLG
timeFrame: 6-9 months
Secondary outcomes:
measure: Volumetric NLG
timeFrame: 6-9 months
measure: Angiographic and volumetric LLL
timeFrame: 6-9 months
measure: TLR
timeFrame: 0-9 months
Other outcomes:
measure: Acute TVF
timeFrame: 0-9 months
Locations:
city: Jena
country: Germany
facility: University Hospital of Jena, Heart Center, Division of Cardiology
Study officials:
affiliation: Jena University Hospital
name: Tudor C Poerner, MD
role: PRINCIPAL_INVESTIGATOR
References: