Coronary Arteries DiseasePhase 2/3BIOHELIX-INCT01612767
BIOHELIX-I Bare Metal Stent Study
A Phase 2/3 study testing PRO-Kinetic Energy Stent in people with Coronary Arteries Disease, run by Biotronik, Inc. at 35 sites in 5 countries.
Trial summary
The purpose of this study is to demonstrate the safety and efficacy of the investigational 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 Arteries 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
- 329 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Nov 2012to Nov 2017
- Phase
- Phase 2/3
- 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
- For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:
- Age ≥ 18 years
- Willingness to comply with study follow-up requirements
- Candidate for a percutaneous coronary intervention (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) Stable angina pectoris is defined as a documented Canadian Cardiovascular Society Classification of I, II, III or IV Unstable angina pectoris is defined as a documented Braunwald Classification of B \& C, I, II, III
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- Written informed consent
- For a subject to receive an investigational stent, the following procedure-related criteria must be met:
- De novo or restenotic lesion in a native coronary artery; restenotic lesions must have been previously treated with only standard percutaneous transluminal coronary angioplasty (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
- For a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:
- 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
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- 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
- 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.
- For a subject to receive an investigational stent the following procedure-related criteria must not be present:
- Documented diagnosis of an acute MI within 72 hours of the index procedure and an elevation of Troponin or creatine kinase-MB (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 left bundle branch block (LBBB) Development of pathological Q-waves in two contiguous leads of the electrocardiogram (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 / µL), thrombocytopenia (platelet count < 100,000 / µL) or thrombocytosis (platelet count > 700,000 / µL)
- Unprotected left main coronary artery disease (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
35 sites in 5 countries.
35 sites in 5 countries
United States28 sites
Study site
Amarillo, Texas, 79106
Study site
Anderson, South Carolina, 29621
Study site
Columbus, Ohio, 43210
Study site
Concord, California, 94520
Study site
Danbury, Connecticut, 06810
Study site
Gainesville, Georgia, 30501
Study site
Gastonia, North Carolina, 28054
Study site
Greenville, South Carolina, 29605
Study site
High Point, North Carolina, 27262
Study site
Indianapolis, Indiana, 46290
Study site
Iowa City, Iowa, 52242
Study site
Kansas City, Missouri, 64132
Study site
Lafayette, Louisiana, 70506
Study site
Lewiston, Maine, 04240
Study site
McKinney, Texas, 75069
Study site
Mechanicsville, Virginia, 23116
Study site
Mission Viejo, California, 92691
Study site
New Haven, Connecticut, 06511
Study site
New York, New York, 10029
Study site
New York, New York, 10065
Study site
Newark, New Jersey, 07102
Study site
Phoenix, Arizona, 85020
Study site
Portland, Oregon, 97239
Study site
Poughkeepsie, New York, 12601
Study site
Springfield, Missouri, 65804
Study site
Takoma Park, Maryland, 20912
Study site
Tyler, Texas, 75701
Study site
Washington D.C., District of Columbia, 20010
Germany3 sites
Study site
Bad Segeberg
Study site
Essen, D-45138
Study site
Ludwigshafen
About this study
Official title: The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent
The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
- Conditions
- Coronary Arteries Disease
- Being tested
- PRO-Kinetic Energy Stent
- Keywords
- de novo coronary lesions, restenotic coronary lesions, coronary arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-Kinetic Energy StentDevice
Coronary artery stent implant
| Study group | Role | What they receive |
|---|---|---|
| Pro-Kinetic Energy Stent | Experimental | Not described Receives: Device: PRO-Kinetic Energy Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure Rate
The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.
Measured: 9 months post-index procedure
Secondary outcomes (13)
Target Vessel Failure Rate
Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.
Measured: 1, 12, 24 and 36 months post-index procedure
Target Vessel Failure Rate - Contribution of Individual Event Types
Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.
Measured: 1, 12, 24 and 36 months post-index procedure
Overall Target Vessel Revascularization Rate
Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.
Measured: 1, 9, 12, 24 and 36 months post-index procedure
Overall Target Lesion Failure Rate
Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.
Measured: 1, 9, 12, 24 and 36 months post-index procedure
Target Lesion Failure Rate - Contribution of Individual Event Types
The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.
Measured: 1, 9, 12, 24, and 36 months post-index procedure
Overall Target Lesion Revascularization Rate
Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.
Measured: 1, 9, 12, 24 and 36 months post-index procedure
Composite of All-cause Mortality and All-cause MI
Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.
Measured: 1, 9, 12, 24, and 36 months post-index procedure
All-cause Mortality and All-cause MI - Contribution of Individual Rates
Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.
Measured: 1, 9, 12, 24, and 36 months post-index procedure
Stent Thrombosis Rate
Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.
Measured: 1, 9, 12, 24 and 36 months post-index procedure
Index Procedure Success
Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.
Measured: Index procedure
Device Success During the Index Procedure
Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.
Measured: Index procedure
Lesion Success During the Index Procedure
Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.
Measured: Index procedure
Angina Pectoris Classification
Evaluate the angina pectoris classification at each study visit.
Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest
Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction
Measured: Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2015
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Arteries DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saurabh Gupta, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612767
- Sponsor's protocol ID
- G110147
- Acronym
- BIOHELIX-I
- Status last verified
- Aug 2018
- First submitted
- 4 Jun 2012
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent
- ClinicalTrials.gov ID
- NCT01612767
- Acronym / sponsor ID
- BIOHELIX-I / G110147
- Conditions
- Coronary Arteries Disease
- Keywords
- de novo coronary lesions, restenotic coronary lesions, coronary arteries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pro-Kinetic Energy Stent | Experimental | Device: PRO-Kinetic Energy Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For a subject to be enrolled in the study and considered for the index procedure, the following initial inclusion criteria must be met:
- Age ≥ 18 years
- Willingness to comply with study follow-up requirements
- Candidate for a percutaneous coronary intervention (PCI) procedure
- Candidate for coronary artery bypass graft surgery
Key exclusion criteria (37 listed)
- For a subject to be enrolled in the study and considered for the index procedure, the following initial exclusion criteria must not be present:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-Kinetic Energy StentCoronary artery stent implant | Device | Pro-Kinetic Energy Stent |
Primary outcome
Target Vessel Failure Rate
Time frame: 9 months post-index procedure
The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.
13 secondary outcomes
Target Vessel Failure Rate
Time frame: 1, 12, 24 and 36 months post-index procedure
Target Vessel Failure Rate - Contribution of Individual Event Types
Time frame: 1, 12, 24 and 36 months post-index procedure
Overall Target Vessel Revascularization Rate
Time frame: 1, 9, 12, 24 and 36 months post-index procedure
Overall Target Lesion Failure Rate
Time frame: 1, 9, 12, 24 and 36 months post-index procedure
Target Lesion Failure Rate - Contribution of Individual Event Types
Time frame: 1, 9, 12, 24, and 36 months post-index procedure
Overall Target Lesion Revascularization Rate
Time frame: 1, 9, 12, 24 and 36 months post-index procedure
Composite of All-cause Mortality and All-cause MI
Time frame: 1, 9, 12, 24, and 36 months post-index procedure
All-cause Mortality and All-cause MI - Contribution of Individual Rates
Time frame: 1, 9, 12, 24, and 36 months post-index procedure
Stent Thrombosis Rate
Time frame: 1, 9, 12, 24 and 36 months post-index procedure
Index Procedure Success
Time frame: Index procedure
Device Success During the Index Procedure
Time frame: Index procedure
Lesion Success During the Index Procedure
Time frame: Index procedure
Angina Pectoris Classification
Time frame: Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saurabh Gupta, MD principal investigator
Oregon Health and Science University
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRO-Kinetic Energy Stent in people with Coronary Arteries Disease, run by Biotronik, Inc. at 35 sites in 5 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 16 inclusion and 37 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Germany, Netherlands, Colombia, Latvia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). 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?
Target Vessel Failure Rate (time frame: 9 months post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2018.