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Coronary Artery DiseaseBIOHELIX-IINCT01811927

The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent

A study testing PRO-Kinetic Energy Stent in people with Coronary Artery Disease, run by Biotronik AG at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to the assess the clinical performance of the BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries. 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?
PRO-Kinetic Energy Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
3 sitesin 2 countries
Study dates
Mar 2013to Oct 2014
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

  • Age > or = 18 years
  • Willingness to comply with study follow-up requirements
  • Candidate for a PCI procedure
  • Candidate for coronary artery bypass graft surgery
  • Documented evidence of stable or unstable angina pectoris or positive functional ischemia study (e.g. exercise treadmill test, thallium stress test, SPECT, stress echocardiogram or cardiac CT)
  • Written informed consent
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  • De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard PTCA (treatment must be > 12 months prior to the index procedure)
  • Target lesion must be in a major coronary artery (target vessel). The target vessel includes the entire territory of the left anterior descending artery, left circumflex artery or right coronary artery and any major side branch of the artery.
  • A maximum of one target lesion and one non-target lesion may be treated per subject. The lesions must be located in separate coronary arteries, with treatment of the non-target lesion occurring first using commercially available therapy (with exception of brachytherapy).
  • Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
  • Target lesion must be treatable with a single investigational stent; an additional stent may be used when treating a vessel dissection or another similar intra-procedure complication (use of investigational stent preferred)
  • Angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate) with a TIMI flow > 1
  • Target lesion length of ≤ 31 mm by operator visual estimate
  • Target vessel reference diameter of 2.25 mm to 4.0 mm by operator visual estimate

Who cannot join

  • Baseline LVEF of < 30%; LVEF may be measured and assessed by standard-of-care echocardiography procedures within 90 days of the index procedure or by a left ventriculogram prior to the index procedure (operator visual assessment)
  • PCI in any vessel 30 days prior to the index procedure or planned for within 30 days after the index procedure
  • Stroke or transient ischemic attack within the last 6 months prior to enrollment
  • Intolerance to contrast agents that cannot be medically managed and/or intolerance to antiplatelet, anticoagulant or thrombolytic medications
  • Refusal of blood transfusions
  • Any other medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
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  • Pregnant, planning to become pregnant or nursing during the course of the study. Women of child-bearing potential must have a negative blood pregnancy (beta hCG) test. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
  • Known allergy to L-605 CoCr alloy (cobalt, chromium, tungsten and nickel) or amorphous silicon carbide
  • Life expectancy of less than one year
  • Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
  • Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or CKMB above the URL (CKMB measurement is not required if CK is normal) at the time of the index procedure (99th percentile of the individual investigative site's normal reference population)
  • For subjects with stable angina and elevated Troponin, CKMB <99% URL is required
  • ECG changes consistent with an acute MI within 72 hours of the index procedure. ECG changes consistent with an acute MI include:
  • > 1 mm ST segment elevation or depression in consecutive leads
  • New LBBB
  • Development of pathological Q-waves in two contiguous leads of the ECG
  • Acute coronary syndrome with baseline Troponin > 99% URL
  • INR ≥ 1.6
  • Concomitant renal failure with serum creatinine level > 2.5 mg/dL
  • Unresolved neutropenia (white blood cell count < 3,000 / SL), thrombocytopenia (platelet count < 100,000 / SL) or thrombocytosis (platelet count > 700,000 / SL)
  • Unprotected left main CAD (> 50% diameter stenosis by operator visual estimate)
  • Target vessel has been treated with any PCI procedure (e.g. PTCA, stent, cutting balloon, atherectomy, etc.) within 12 months prior to the index procedure
  • Target lesion has been treated with a stent, cutting balloon or atherectomy any time prior to the index procedure or has been treated with PTCA within 12 months prior to the index procedure
  • Target vessel treated with brachytherapy anytime prior to index procedure
  • Planned PCI in the target vessel within 9 months after the index procedure
  • Target vessel has a non-target lesion with a > 50% stenosis that requires treatment during the index procedure
  • Lesions preventing distal perfusion (TIMI flow 0 and 1) prior to wire crossing
  • Target lesion is in the left main coronary artery or within 2 mm of the origin of the left anterior descending artery or left circumflex artery by operator visual estimate
  • Target lesion is located within a saphenous vein graft or arterial graft
  • Target lesion involves a bifurcation - lesion is located in a major coronary artery and involves a side branch with a diameter > 2 mm (by operator visual estimate)
  • Presence of a complication following pre-dilatation of target lesion
  • Presence of a complication following treatment of a non-target lesion (if applicable)
  • Presence of a target vessel/lesion that has excessive tortuousity/angulation or is severely calcified preventing complete inflation of an angioplasty balloon
  • Angiographic evidence of thrombus within the target lesion
  • Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
  • Use of cutting balloons, atherectomy or ablative devices immediately prior to investigational stent placement

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Switzerland2 sites

  • University Hospital of Basel

    Basel, 4031

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Netherlands1 site

  • St. Antonius Hospital

    Nieuwegein, 3435

Other trials in Netherlands

About this study

Official title: The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II)

The purpose of this study is to the assess the clinical performance of the BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.

Being tested
PRO-Kinetic Energy Stent
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.

  • PRO-Kinetic Energy StentDevice

    Bare-metal stent

Study groups in NCT01811927
Study groupRoleWhat they receive
PRO-Kinetic Energy StentExperimentalPRO-Kinetic Energy Stent
Receives: Device: PRO-Kinetic Energy Stent

What is being measured

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

  1. In-stent late lumen loss

    Measured: 9-months 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 posted15 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01811927
Sponsor's protocol ID
C1210
Acronym
BIOHELIX-II
Status last verified
Mar 2015
First submitted
13 Mar 2013
Last updated
24 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing PRO-Kinetic Energy Stent in people with Coronary Artery Disease, run by Biotronik AG at 3 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 14 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 was stopped early. Results are not available in the source record.

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 (time frame: 9-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 NCT01811927.

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 24 Mar 2015.

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