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

NCT02607241 | Terminated Phase 4 DMC

• 1 other identifier: UKJ-TCP-3
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

drug-coated balloon; bioresorbable scaffold; fractional flow reserve; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Angiographic NLG

  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

  6-9 months

Secondary Outcomes (3)

• Volumetric NLG

  6-9 months

• Angiographic and volumetric LLL

  6-9 months

• TLR

  0-9 months

Other Outcomes (1)

• Acute TVF

  0-9 months

Study Arms (2)

BRS

ACTIVE COMPARATOR

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

DCB-only

EXPERIMENTAL

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

Interventions

OCT-guided BRS implantation 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

BRS

FFR-guided DCB-only PCI 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).

DCB-only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead
• KKS Netzwerk: collaborator

Study Sites (1)

University Hospital of Jena, Heart Center, Division of Cardiology

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tudor C Poerner, MD

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Tudor C. Poerner

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

DE (1)