Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation

September 2, 2016 updated by: Qvanteq AG

Objective of this First in Man study is to assess feasibility and safety of Qvanteq's bioactive coronary stent for treatment of stable coronary artery disease patients with de novo coronary artery stenosis in native vessels.

The proprietary surface of Qvanteq's bioactive coronary stent improves the in-growth behavior of the stent in the treated vessel. In-vivo animal studies revealed fast in-growth (similar to BMS), which however is not resulting in excessive tissue overgrowth as observed in BMS but rather has an efficacy profile similar to drug-eluting stent (DES), meaning suppression of tissue overgrowth. This should reduce the risk of restenosis and thrombus formation despite the presence of a short term dual anti platelet therapy (DAPT). Furthermore, prolonged DAPT time as applied with current DES increases the bleeding risk of patients.

The study is a prospective, multicenter, open-label, single arm study; conducted in up to 6 cardiology centers in CH and NL. In total, approx. 35 patients will be enrolled. All patients will be treated with the Qvanteq's bioactive coronary stent. Clinical follow-up will occur at 1, 6 & 12 months post-stent implantation. All patients will undergo angiography assessment (QCA) and Optical Coherence Tomography investigation (OCT) at baseline and at 6 months follow-up. Baseline OCT should be performed after the successfully completed angiographic procedure (documentary OCT). 1 and 12 months clinical follow-ups are conducted via telephone.

Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months; assessed by off-line QCA. Primary OCT endpoint is mean neointimal thickness at 6 months; assessed by off-line OCT analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Enschede, Netherlands, 7513
        • Thoraxcentrum Twente, Medisch Spectrum Twente
      • Rotterdam, Netherlands, 3015
        • Thoraxcenter Erasmus MC Universitair Medisch Centrum Rotterdam
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern
      • Geneva, Switzerland, 1205
        • Cardiologie interventionnelle HUG - Hôpitaux Universitaires de Genève
      • Zürich, Switzerland, 8032
        • Herzklinik Hirslanden
      • Zürich, Switzerland, 8063
        • Stadtspital Triemli Zürich Klinik für Kardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be at least 18 years of age
  • Evidence of myocardial ischemia without elevated cardiac biomarkers (e.g. stable or unstable angina with stable haemodynamic condition, silent ischemia demonstrated by positive territorial functional study)
  • The patient has a planned intervention of one single de novo lesion in one or two separate major epicardial territories (LAD, LCX, or RCA).
  • The lesion must have a visually estimated diameter stenosis of ≥ 50% and < 100%
  • Lesion length must be ≤16 mm
  • The vessel size must be between 2.5 and 3.5 mm
  • Written informed consent
  • The patient agrees to the follow-up visits including angiographic follow-up and OCT control at 6 months

Key Exclusion Criteria:

  • Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
  • Patient suffered from stroke/TIA or myocardial infarction during the last 6 months
  • LVEF <30%
  • Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Known renal insufficiency (Creatinine clearance less than 30 mL/Min), or subject on dialysis, or acute kidney failure
  • Patient undergoing planned surgery within 6 months with the necessity to stop ASA
  • Patient requiring prolonged DAPT for other diagnoses (>1 month)
  • History of bleeding diathesis or coagulopathy
  • Patient requiring oral anticoagulation (Coumadin, NOAC)
  • The patient is a recipient of a heart transplant
  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or cobalt-chromium
  • Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
  • Female of child bearing potential (age <50 years and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy.
  • Previous CABG

Angiographic Exclusion Criteria:

  • Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
  • Target lesion in left main stem.
  • Target lesion involves a side branch > 2.0mm in diameter
  • Aorto-ostial target lesion (within 3 mm of the aorta junction).
  • Total occlusion or TIMI flow <3, prior to wire crossing
  • The target vessel contains visible thrombus
  • Restenotic lesion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qvanteq bioactive coronary stent system
Open-label, single arm, non-randomized study
Device: Qvanteq bioactive coronary stent
PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent Late Lumen Loss (LLL) assessed by off-line QCA
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Mean neointimal thickness assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute lumen gain assessed by off-line QCA
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
In-segment Late Lumen Loss assessed by off-line QCA
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Mean Lumen Diameter (MLD) assessed by off-line QCA
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Diameter stenosis assessed by off-line QCA
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Binary restenosis (diameter stenosis > = 50%) assessed by off-line QCA
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Prolapse area/volume assessed by off-line OCT analysis
Time Frame: At baseline
At baseline
Mean/minimal lumen diameter/area/volume assessed by off-line OCT analysis
Time Frame: At baseline and at 6 months after stent implantation
At baseline and at 6 months after stent implantation
Mean/minimal stent diameter/area/volume assessed by off-line OCT analysis
Time Frame: At baseline and at 6 months after stent implantation
At baseline and at 6 months after stent implantation
Stent symmetry assessed by off-line OCT analysis
Time Frame: At baseline and at 6 months after stent implantation
At baseline and at 6 months after stent implantation
Stent expansion assessed by off-line OCT analysis
Time Frame: At baseline and at 6 months after stent implantation
At baseline and at 6 months after stent implantation
Incomplete strut apposition assessed by off-line OCT analysis
Time Frame: At baseline and at 6 months after stent implantation
At baseline and at 6 months after stent implantation
In-stent neointimal hyperplasia volume obstruction (%) assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Neointimal hyperplasia area/volume assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Mean/maximal thickness of the struts coverage assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Percentage number of covered struts assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Percentage of incomplete apposed struts assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Healing score assessed by off-line OCT analysis
Time Frame: At 6 months after stent implantation
At 6 months after stent implantation
Acute success (device and procedural)
Time Frame: At baseline
At baseline
Device-oriented composite endpoints (cardiac death, MI not clearly attributable to a non-intervention vessel, clinically indicated target lesion revascularization)
Time Frame: At 1, 6 and 12 months after stent implantation
At 1, 6 and 12 months after stent implantation
Myocardial infarction (Q-wave, Non q-wave)
Time Frame: At 1, 6 and 12 months after stent implantation
At 1, 6 and 12 months after stent implantation
Clinically indicated revascularization of the target vessel
Time Frame: At 1, 6 and 12 months after stent implantation
At 1, 6 and 12 months after stent implantation
Any revascularization
Time Frame: At 1, 6 and 12 months after stent implantation
At 1, 6 and 12 months after stent implantation
Stent thrombosis according to ARC definitions
Time Frame: Up to 12 months after stent implantation
Up to 12 months after stent implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qvanteq AG

Collaborators

Cardialysis BV

Investigators

  • Principal Investigator: Lorenz Räber, MD, Dep. of Cardiology, University Hospital Bern, Switzerland
  • Study Chair: Patrick W Serruys, Prof, Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUEST I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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