Clinical trial NCT01612767: BIOHELIX-I Bare Metal Stent Study
Official title: The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Arteries Disease
Keywords: de novo coronary lesions
restenotic coronary lesions
coronary arteries
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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
* 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

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 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

Primary outcomes:
measure: Target Vessel Failure Rate
timeFrame: 9 months post-index procedure
Secondary outcomes:
measure: Target Vessel Failure Rate
timeFrame: 1, 12, 24 and 36 months post-index procedure
measure: Target Vessel Failure Rate - Contribution of Individual Event Types
timeFrame: 1, 12, 24 and 36 months post-index procedure
measure: Overall Target Vessel Revascularization Rate
timeFrame: 1, 9, 12, 24 and 36 months post-index procedure
measure: Overall Target Lesion Failure Rate
timeFrame: 1, 9, 12, 24 and 36 months post-index procedure
measure: Target Lesion Failure Rate - Contribution of Individual Event Types
timeFrame: 1, 9, 12, 24, and 36 months post-index procedure
measure: Overall Target Lesion Revascularization Rate
timeFrame: 1, 9, 12, 24 and 36 months post-index procedure
measure: Composite of All-cause Mortality and All-cause MI
timeFrame: 1, 9, 12, 24, and 36 months post-index procedure
measure: All-cause Mortality and All-cause MI - Contribution of Individual Rates
timeFrame: 1, 9, 12, 24, and 36 months post-index procedure
measure: Stent Thrombosis Rate
timeFrame: 1, 9, 12, 24 and 36 months post-index procedure
measure: Index Procedure Success
timeFrame: Index procedure
measure: Device Success During the Index Procedure
timeFrame: Index procedure
measure: Lesion Success During the Index Procedure
timeFrame: Index procedure
measure: Angina Pectoris Classification
timeFrame: Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Concord
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Lafayette
country: United States
state: Louisiana
city: Lewiston
country: United States
state: Maine
city: Takoma Park
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Anderson
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Amarillo
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Mechanicsville
country: United States
state: Virginia
city: Medellin
country: Colombia
city: Bad Segeberg
country: Germany
city: Essen
country: Germany
city: Ludwigshafen
country: Germany
city: Riga
country: Latvia
city: Amsterdam
country: Netherlands
city: Eindhoven
country: Netherlands
Study officials:
affiliation: Oregon Health and Science University
name: Saurabh Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: