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

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ClinicalTrials.gov Identifier: NCT02176265
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : September 5, 2016
Sponsor:
Collaborator:
Cardialysis BV
Information provided by (Responsible Party):
Qvanteq AG

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Qvanteq bioactive coronary stent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation
Study Start Date : September 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Qvanteq bioactive coronary stent system
Open-label, single arm, non-randomized study
 Device: Qvanteq bioactive coronary stent
PCI


Outcome Measures
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Primary Outcome Measures :
  1. In-stent Late Lumen Loss (LLL) assessed by off-line QCA [ Time Frame: At 6 months after stent implantation ]
  2. Mean neointimal thickness assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]

Secondary Outcome Measures :
  1. Acute lumen gain assessed by off-line QCA [ Time Frame: At 6 months after stent implantation ]
  2. In-segment Late Lumen Loss assessed by off-line QCA [ Time Frame: At 6 months after stent implantation ]
  3. Mean Lumen Diameter (MLD) assessed by off-line QCA [ Time Frame: At 6 months after stent implantation ]
  4. Diameter stenosis assessed by off-line QCA [ Time Frame: At 6 months after stent implantation ]
  5. Binary restenosis (diameter stenosis > = 50%) assessed by off-line QCA [ Time Frame: At 6 months after stent implantation ]
  6. Prolapse area/volume assessed by off-line OCT analysis [ Time Frame: At baseline ]
  7. Mean/minimal lumen diameter/area/volume assessed by off-line OCT analysis [ Time Frame: At baseline and at 6 months after stent implantation ]
  8. Mean/minimal stent diameter/area/volume assessed by off-line OCT analysis [ Time Frame: At baseline and at 6 months after stent implantation ]
  9. Stent symmetry assessed by off-line OCT analysis [ Time Frame: At baseline and at 6 months after stent implantation ]
  10. Stent expansion assessed by off-line OCT analysis [ Time Frame: At baseline and at 6 months after stent implantation ]
  11. Incomplete strut apposition assessed by off-line OCT analysis [ Time Frame: At baseline and at 6 months after stent implantation ]
  12. In-stent neointimal hyperplasia volume obstruction (%) assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]
  13. Neointimal hyperplasia area/volume assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]
  14. Mean/maximal thickness of the struts coverage assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]
  15. Percentage number of covered struts assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]
  16. Percentage of incomplete apposed struts assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]
  17. Healing score assessed by off-line OCT analysis [ Time Frame: At 6 months after stent implantation ]
  18. Acute success (device and procedural) [ Time Frame: At baseline ]
  19. 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 ]
  20. Myocardial infarction (Q-wave, Non q-wave) [ Time Frame: At 1, 6 and 12 months after stent implantation ]
  21. Clinically indicated revascularization of the target vessel [ Time Frame: At 1, 6 and 12 months after stent implantation ]
  22. Any revascularization [ Time Frame: At 1, 6 and 12 months after stent implantation ]
  23. Stent thrombosis according to ARC definitions [ Time Frame: Up to 12 months after stent implantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176265


Locations
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Netherlands
Thoraxcentrum Twente, Medisch Spectrum Twente
Enschede, Netherlands, 7513
Thoraxcenter Erasmus MC Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands, 3015
Switzerland
Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern
Bern, Switzerland, 3010
Cardiologie interventionnelle HUG - Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
HerzKlinik Hirslanden
Zürich, Switzerland, 8032
Stadtspital Triemli Zürich Klinik für Kardiologie
Zürich, Switzerland, 8063
Sponsors and Collaborators
Qvanteq AG
Cardialysis BV
Investigators
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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
More Information
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Publications:

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Responsible Party: Qvanteq AG
ClinicalTrials.gov Identifier: NCT02176265    
Other Study ID Numbers: QUEST I
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Keywords provided by Qvanteq AG:
CAD
PCI
bioactive coronary stent
OCT
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases