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Coronary Artery DiseaseDIRECT IINCT01788150

Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System

A study testing Coronary Stenting in people with Coronary Artery Disease, run by Svelte Medical Systems, Inc. at 18 sites in 7 countries.

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

A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent. 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?
Coronary Stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
18 sitesin 7 countries
Study dates
Jan 2013to 31 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • General Inclusion Criteria
  • Patient is ≥18 years old;
  • Patient is eligible for percutaneous coronary intervention (PCI);
  • Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
  • Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
  • Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
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  • Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and
  • Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
  • Angiographic Inclusion Criteria
  • Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;
  • If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
  • Residual diameter stenosis < 30%;
  • Absence of any angiographic complications;
  • Absence of ischemic symptoms; and
  • Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.
  • Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
  • Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and
  • Target lesion stenosis ≥ 50% and < 100% by visual estimate.

Who cannot join

  • General Exclusion Criteria
  • Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
  • The patient requires a staged procedure of the target vessel within 6-months or a staged procedure of a non-target vessel within 30-days post-procedure;
  • The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);
  • Any DES deployment anywhere in the target vessel within the past 9-months;
  • Any BMS deployment anywhere in the target vessel within the past 6-months;
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  • Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
  • Myocardial infarction within 72-hours of the index procedure, with the exception of:
  • Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72-hours;
  • Patients who have had a non-STEMI may be included if their troponin levels are within the laboratory normal range within 24-hours pre-procedure.
  • Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
  • Concurrent medical condition with a life expectancy of less than 12-months;
  • Documented left ventricular ejection fraction (LVEF) ≤ 30%;
  • Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
  • Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
  • Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;
  • Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);
  • History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
  • Patients requiring ongoing anticoagulation with warfarin or dabigatran.
  • Angiographic Exclusion Criteria
  • Total occlusion (TIMI 0 or 1);
  • Target vessel has angiographic evidence of thrombus
  • Target vessel is excessively tortuous or has heavy calcification;
  • Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
  • Target lesion is located in or supplied by an arterial or venous bypass graft;
  • Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
  • Target lesion involves a side branch > 2.0 mm in diameter; and
  • Unprotected Left Main coronary disease (stenosis > 50%).

Trial locations and contacts

18 sites in 7 countries.

18 sites in 7 countries

Netherlands5 sites

  • OLVG Amsterdam

    Amsterdam

  • Catharina Hospital Eindhoven

    Eindhoven

  • Erasmus MC

    Rotterdam

  • Maasstad Ziekenhuis

    Rotterdam

  • University Medical Center Utrecht, Department of Cardiology

    Utrecht

Other trials in Netherlands

Belgium4 sites

  • OLV Ziekenhuis Aalst

    Aalst

  • Middelheim Ziekenhuis

    Antwerp

  • ZOL Genk

    Genk

  • CHU Liège

    Liège

Other trials in Belgium

France3 sites

  • Clinique Saint-Hilaire

    Rouen

  • CHU de Toulouse

    Toulouse

  • Clinique Pasteur

    Toulouse

Other trials in France

Germany2 sites

  • Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer

    Hamburg

  • University Medical Center Hamburg-Eppendorf

    Hamburg

Other trials in Germany

Sweden2 sites

  • Skane University Hospital

    Malmö

  • Södersjukhuset

    Stockholm

Other trials in Sweden

Czechia1 site

  • Všeobecná fakultní nemocnice Praha

    Prague

Other trials in Czechia

Switzerland1 site

  • Inselspital

    Bern

Other trials in Switzerland

About this study

Official title: Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

Being tested
Coronary Stenting
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.

  • Coronary StentingDevice

Study groups in NCT01788150
Study groupRoleWhat they receive
Svelte Drug-Eluting Coronary StentExperimentalCoronary Stenting
Receives: Device: Coronary Stenting
Medtronic Resolute Integrity Drug-Eluting StentActive comparatorCoronary Stenting
Receives: Device: Coronary Stenting

What is being measured

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

  1. Angiographic In-Stent Late Lumen Loss (LL)

    Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.

    Measured: 6-months post-procedure

Secondary outcomes (11)

  1. Number of Participants Clinically-driven Target Lesion Revascularization (TLR)

    Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.

    Measured: 1 year post-procedure

  2. Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization

    Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization

    Measured: 1 year post-procedure

  3. Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels

    Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels

    Measured: 1 year post-procedure

  4. Number of Participants Stent Thrombosis

    The sudden occlusion of a stented coronary artery due to thrombus formation.

    Measured: 1 year post-procedure

  5. Number of Participants Acute Success Rates

    Direct Stenting Success, Lesion Success, Procedure Success and Device Failure

    Measured: From index procedure to hospital discharge, an average of 24 hours

  6. Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate

    The rate which restenosis occurs

    Measured: 6-months post-procedure

  7. In-stent and In-segment Minimum Lumen Diameter

    Smallest diameter in the stent or segment area

    Measured: 6-months post-procedure

  8. In-segment Late Lumen Loss

    Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram

    Measured: 6-months post-procedure

  9. Neointimal Hyperplasia as Measured by OCT

    (% lumen volume)

    Measured: 6-months post procedures

  10. Strut Coverage

    (% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)

    Measured: 6-months post procedure

  11. Number of Participants Target Vessel Failure

    Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.

    Measured: 1 year post procedure

Timeline

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

  1. First posted11 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2014
  4. Study completion31 May 2019

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788150
Sponsor's protocol ID
IP-12-002
Acronym
DIRECT II
Status last verified
Apr 2021
First submitted
5 Feb 2013
Last updated
4 May 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Stenting in people with Coronary Artery Disease, run by Svelte Medical Systems, Inc. at 18 sites in 7 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 18 inclusion and 30 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Netherlands, Belgium, France, Germany, Sweden and 2 more countries. 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?

Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Angiographic In-Stent Late Lumen Loss (LL) (time frame: 6-months post-procedure). 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 NCT01788150.

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 4 May 2021.

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