AzTrials
AzTrials

Coronary Artery DiseaseNCT02176265

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

A study testing Qvanteq bioactive coronary stent in people with Coronary Artery Disease, run by Qvanteq AG at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Qvanteq bioactive coronary stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
6 sitesin 2 countries
Study dates
Sep 2014to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Switzerland4 sites

  • Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern

    Bern, 3010

  • Cardiologie interventionnelle HUG - Hôpitaux Universitaires de Genève

    Geneva, 1205

  • HerzKlinik Hirslanden

    Zurich, 8032

  • Stadtspital Triemli Zürich Klinik für Kardiologie

    Zurich, 8063

Other trials in Switzerland

Netherlands2 sites

  • Thoraxcentrum Twente, Medisch Spectrum Twente

    Enschede, 7513

  • Thoraxcenter Erasmus MC Universitair Medisch Centrum Rotterdam

    Rotterdam, 3015

Other trials in Netherlands

About this study

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.

Read more

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.

Being tested
Qvanteq bioactive coronary stent
Keywords
CAD, PCI, bioactive coronary stent, OCT
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qvanteq bioactive coronary stentDevice

    PCI

Study groups in NCT02176265
Study groupRoleWhat they receive
Qvanteq bioactive coronary stent systemExperimentalOpen-label, single arm, non-randomized study
Receives: Device: Qvanteq bioactive coronary stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent Late Lumen Loss (LLL) assessed by off-line QCA

    Measured: At 6 months after stent implantation

  2. Mean neointimal thickness assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

Secondary outcomes (23)

  1. Acute lumen gain assessed by off-line QCA

    Measured: At 6 months after stent implantation

  2. In-segment Late Lumen Loss assessed by off-line QCA

    Measured: At 6 months after stent implantation

  3. Mean Lumen Diameter (MLD) assessed by off-line QCA

    Measured: At 6 months after stent implantation

  4. Diameter stenosis assessed by off-line QCA

    Measured: At 6 months after stent implantation

  5. Binary restenosis (diameter stenosis > = 50%) assessed by off-line QCA

    Measured: At 6 months after stent implantation

  6. Prolapse area/volume assessed by off-line OCT analysis

    Measured: At baseline

  7. Mean/minimal lumen diameter/area/volume assessed by off-line OCT analysis

    Measured: At baseline and at 6 months after stent implantation

  8. Mean/minimal stent diameter/area/volume assessed by off-line OCT analysis

    Measured: At baseline and at 6 months after stent implantation

  9. Stent symmetry assessed by off-line OCT analysis

    Measured: At baseline and at 6 months after stent implantation

  10. Stent expansion assessed by off-line OCT analysis

    Measured: At baseline and at 6 months after stent implantation

  11. Incomplete strut apposition assessed by off-line OCT analysis

    Measured: At baseline and at 6 months after stent implantation

  12. In-stent neointimal hyperplasia volume obstruction (%) assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

  13. Neointimal hyperplasia area/volume assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

  14. Mean/maximal thickness of the struts coverage assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

  15. Percentage number of covered struts assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

  16. Percentage of incomplete apposed struts assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

  17. Healing score assessed by off-line OCT analysis

    Measured: At 6 months after stent implantation

  18. Acute success (device and procedural)

    Measured: At baseline

  19. Device-oriented composite endpoints (cardiac death, MI not clearly attributable to a non-intervention vessel, clinically indicated target lesion revascularization)

    Measured: At 1, 6 and 12 months after stent implantation

  20. Myocardial infarction (Q-wave, Non q-wave)

    Measured: At 1, 6 and 12 months after stent implantation

  21. Clinically indicated revascularization of the target vessel

    Measured: At 1, 6 and 12 months after stent implantation

  22. Any revascularization

    Measured: At 1, 6 and 12 months after stent implantation

  23. Stent thrombosis according to ARC definitions

    Measured: Up to 12 months after stent implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02176265
Sponsor's protocol ID
QUEST I
Status last verified
Sep 2016
First submitted
25 Jun 2014
Last updated
5 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.

    PubMed 17321312

  • Raber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Juni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012 Mar 6;125(9):1110-21. doi: 10.1161/CIRCULATIONAHA.111.058560. Epub 2012 Feb 1.

    PubMed 22302840

  • Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.

    PubMed 20060578

  • Ndrepepa G, Schuster T, Hadamitzky M, Byrne RA, Mehilli J, Neumann FJ, Richardt G, Schulz S, Laugwitz KL, Massberg S, Schomig A, Kastrati A. Validation of the Bleeding Academic Research Consortium definition of bleeding in patients with coronary artery disease undergoing percutaneous coronary intervention. Circulation. 2012 Mar 20;125(11):1424-31. doi: 10.1161/CIRCULATIONAHA.111.060871. Epub 2012 Feb 17.

    PubMed 22344040

  • Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

    PubMed 17438147

  • Guagliumi G, Sirbu V, Musumeci G, Gerber R, Biondi-Zoccai G, Ikejima H, Ladich E, Lortkipanidze N, Matiashvili A, Valsecchi O, Virmani R, Stone GW. Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. JACC Cardiovasc Interv. 2012 Jan;5(1):12-20. doi: 10.1016/j.jcin.2011.09.018.

    PubMed 22230145

  • Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C; BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006 Dec 19;48(12):2584-91. doi: 10.1016/j.jacc.2006.10.026. Epub 2006 Nov 2.

    PubMed 17174201

  • Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA. 2007 Jan 10;297(2):159-68. doi: 10.1001/jama.297.2.joc60179. Epub 2006 Dec 5.

    PubMed 17148711

  • Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.

    PubMed 20231231

  • Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.

    PubMed 22179532

  • Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.

    PubMed 22438530

  • Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.

    PubMed 20802248

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PubMed 21670242

  • Soehnlein O, Wantha S, Simsekyilmaz S, Doring Y, Megens RT, Mause SF, Drechsler M, Smeets R, Weinandy S, Schreiber F, Gries T, Jockenhoevel S, Moller M, Vijayan S, van Zandvoort MA, Agerberth B, Pham CT, Gallo RL, Hackeng TM, Liehn EA, Zernecke A, Klee D, Weber C. Neutrophil-derived cathelicidin protects from neointimal hyperplasia. Sci Transl Med. 2011 Oct 5;3(103):103ra98. doi: 10.1126/scitranslmed.3002531.

    PubMed 21974936

Questions about this trial

What is this clinical trial studying?

A study testing Qvanteq bioactive coronary stent in people with Coronary Artery Disease, run by Qvanteq AG at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent Late Lumen Loss (LLL) assessed by off-line QCA (time frame: At 6 months after stent implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02176265, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in