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Coronary Artery DiseaseNCT01761578

ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent

A study testing ART18Z Bioresorbable stent in people with Coronary Artery Disease, run by Arterial Remodeling Technologies at 5 sites in France.

Completed

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

Official record
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Trial summary

This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
ART18Z Bioresorbable stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesFrance
Study dates
Jun 2012to Jun 2013
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Angiographic Inclusion Criteria:
  • Target lesion must meet all of the following criteria
  • Single vessel lesion
  • De novo lesion
  • Located in a native coronary artery with visually estimated nominal artery diameter of 2.8 to 3.2 mm
  • Length ≤ 8 mm visually estimated
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  • Located in a major artery or branch with a visually estimated stenosis >50% and <100% with a TIMI flow ≥1
  • General Inclusion Criteria:
  • Patient profile:
  • Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ART18Z Bioresorbable Stent.
  • Patient provides written informed consent approved by the EC prior to any clinical investigation related procedure
  • Patient must agree to undergo all clinical investigation plan - required clinical follow-up visits, QCA, OCT
  • Patient must agree not to participate in any other clinical investigation for a period of 3 years following the procedure
  • a social security number is required, otherwise patients cannot be included in the trial.
  • Clinical profile:
  • Silent ischemia, stable or unstable angina with documented ischemia (stress echocardiography, 12-lead ECG, nuclear imaging, bicycle test, Treadmill stress test)
  • 3 months limited clopidogrel treatment must be acceptable in compliance with patient health status
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

Who cannot join

  • Angiographic Exclusion Criteria:
  • Target lesion meets any of the following criteria:
  • Aorto-ostial location (within 3 mm)
  • Left main location
  • located within 3 mm of the origin of the LAD or LCX
  • Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and >20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
Show all 36Show fewer
  • Lesion involving a bifurcation ≥ 1.5 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
  • Excessive tortuosity proximal to or within the lesion (Extreme angulation (≥ 90%) proximal)
  • Calcification lesion
  • Restenotic from previous intervention
  • The target vessel contains visible thrombus
  • Chronic total occlusion (CTO)
  • Another clinically significant lesion is located in the same major epicardial vessel as the target lesion (including side branches)
  • Patient has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)
  • Non clinical investigation percutaneous intervention in the target vessel < 6 months prior to or if planned to be done within 6 months after the investigational procedure.
  • Non clinical investigation percutaneous intervention in a non-target vessel < 1 months prior to the investigational procedure with TIMI flow = 3 and no evidence of dissection at the time of the clinical investigation procedure, or if planned to be done within 6 months after the investigational procedure.
  • General Exclusion Criteria
  • Evidence of an acute MI within 3 weeks of the intended investigational procedure
  • Patient has current unstable arrhythmias
  • Patient has a known left ventricular ejection fraction (LVEF) < 30%
  • Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
  • Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  • Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, or contrast sensitivity that cannot be adequately pre-medicated
  • Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
  • Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Patient has known renal insufficiency with creatine clearance < 40 ml/min or patient on dialysis
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Patient has had a cerebro vascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • Patient has had a significant GI or urinary bleed within the past six months
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  • Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a < 24 months limited life expectancy
  • Vulnerable population (refer to §6.4)
  • Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
  • Pregnant or nursing patients and those who plan pregnancy during the clinical investigation.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Polyclinique les Fleurs

    Ollioules

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Haut Leveque

    Pessac

  • Clinique Pasteur

    Toulouse

  • Hôpital Rangueil

    Toulouse

Other trials in France

About this study

Official title: First in Man Safety Evaluation of the ART18Z Bioresorbable Stent for the Treatment of Single de Novo Lesion of a Native Coronary Artery.

This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.

Being tested
ART18Z Bioresorbable stent
Keywords
Bioresorbable, Coronary, Stent, Vascular Remodeling, Angioplasty, Coronary Artery Disease
Medical subject headings
Coronary Artery Disease, Vascular Remodeling

What participants receive

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

  • ART18Z Bioresorbable stentDevice

    The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.

Study groups in NCT01761578
Study groupRoleWhat they receive
ART18Z Bioresorbable stentExperimentalNot described
Receives: Device: ART18Z Bioresorbable stent

What is being measured

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

  1. MACE rate

    Major Adverse Cardiac Event is defined as death, MI (Myocardial Infarction) or any TLR (Target Lesion Revascularization).

    Measured: at 6 months

Secondary outcomes (7)

  1. Acute Performances (Device/Procedure Success)

    Measured: Procedure and post-procedure up to 24 hours

  2. Stent thrombosis

    Measured: at 1, 3, 6, 12, 18 months

  3. Clinically driven TVF, TLR, TVR

    Measured: at 1, 3, 6, 12, 18 months

  4. Evolution of Angiographic binary restenosis

    Measured: at 12 months

  5. Evolution of Angiographic in-stent Late Lumen Loss

    Measured: at 12 months

  6. Percentage of stent coverage by OCT

    Measured: at 12 months

  7. Evolution of the neointima by OCT

    Measured: at 12 months

Timeline

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

  1. First posted7 Jan 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2013

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01761578
Sponsor's protocol ID
ARTDIVA
Status last verified
Jan 2015
First submitted
3 Jan 2013
Last updated
14 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ART18Z Bioresorbable stent in people with Coronary Artery Disease, run by Arterial Remodeling Technologies at 5 sites in France.

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 18 inclusion and 36 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 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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?

MACE rate (time frame: at 6 months). 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 NCT01761578.

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 14 Jan 2015.

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