BIOHELIX-I Bare Metal Stent Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Biotronik, Inc.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT01612767
First received: June 4, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Coronary Arteries Disease
Device: PRO-Kinetic Energy Stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • The primary endpoint for the study is the target vessel failure rate [ Time Frame: 9 months post index procedure ] [ Designated as safety issue: Yes ]
    Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.


Secondary Outcome Measures:
  • Target Vessel Failure rate [ Time Frame: 1, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization

  • Overall TVR rate [ Time Frame: 1, 9, 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    overall target vessel revascularization

  • Target lesion failure rate [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
    target lesion failure including contribution of each event to composite rate

  • Overall target lesion revascularization rate [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
  • Composite of all-cause mortality and all-cause MI [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
    This includes contribution of each event to overall composite rate

  • Stent thrombosis rate [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
  • Index procedure success [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
  • Device success during the index procedure [ Time Frame: index procedure ] [ Designated as safety issue: Yes ]
  • Lesion success during the index procedure [ Time Frame: index procedure ] [ Designated as safety issue: Yes ]
  • Angina pectoris classification [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]
  • Rates of all adverse events not included in the evaluation of the primary endpoint [ Time Frame: 1, 9, 12, 24 and 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 329
Study Start Date: November 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pro-Kinetic Energy Stent Device: PRO-Kinetic Energy Stent
Coronary artery stent implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 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
  • 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 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

Exclusion Criteria:

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
  • 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 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

  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612767

Contacts
Contact: Amy Culley 503-451-8034 amy.culley@biotronik.com

  Show 37 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
Investigators
Principal Investigator: Saurabh Gupta, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01612767     History of Changes
Other Study ID Numbers: G110147
Study First Received: June 4, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biotronik, Inc.:
de novo coronary lesions
restenotic coronary lesions
coronary arteries

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014