BIOHELIX-I Bare Metal Stent Study

NCT01612767 | Completed Phase 2 Results DMC

• 1 other identifier: G110147
• Study Type: interventional
• Target: 329
• Locations: 5 countries
• Sites: 35

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.

Conditions

Coronary Arteries Disease

Keywords

de novo coronary lesions; restenotic coronary lesions; coronary arteries

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months post-index procedure

Secondary Outcomes (13)

• Target Vessel Failure Rate

  1, 12, 24 and 36 months post-index procedure

• Target Vessel Failure Rate - Contribution of Individual Event Types

  1, 12, 24 and 36 months post-index procedure

• Overall Target Vessel Revascularization Rate

  1, 9, 12, 24 and 36 months post-index procedure

• Overall Target Lesion Failure Rate

  1, 9, 12, 24 and 36 months post-index procedure

• Target Lesion Failure Rate - Contribution of Individual Event Types

  1, 9, 12, 24, and 36 months post-index procedure

Study Arms (1)

Pro-Kinetic Energy Stent

EXPERIMENTAL

Device: PRO-Kinetic Energy Stent

Interventions

PRO-Kinetic Energy Stent DEVICE

Coronary artery stent implant

Pro-Kinetic Energy Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (35)

Unknown Facility

Phoenix, Arizona, 85020, United States

Location

Unknown Facility

Concord, California, 94520, United States

Location

Unknown Facility

Mission Viejo, California, 92691, United States

Location

Unknown Facility

Danbury, Connecticut, 06810, United States

Location

Unknown Facility

New Haven, Connecticut, 06511, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Gainesville, Georgia, 30501, United States

Location

Unknown Facility

Indianapolis, Indiana, 46290, United States

Location

Unknown Facility

Iowa City, Iowa, 52242, United States

Location

Unknown Facility

Lafayette, Louisiana, 70506, United States

Location

Unknown Facility

Lewiston, Maine, 04240, United States

Location

Unknown Facility

Takoma Park, Maryland, 20912, United States

Location

Unknown Facility

Kansas City, Missouri, 64132, United States

Location

Unknown Facility

Springfield, Missouri, 65804, United States

Location

Unknown Facility

Newark, New Jersey, 07102, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Poughkeepsie, New York, 12601, United States

Location

Unknown Facility

Gastonia, North Carolina, 28054, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Anderson, South Carolina, 29621, United States

Location

Unknown Facility

Greenville, South Carolina, 29605, United States

Location

Unknown Facility

Amarillo, Texas, 79106, United States

Location

Unknown Facility

McKinney, Texas, 75069, United States

Location

Unknown Facility

Tyler, Texas, 75701, United States

Location

Unknown Facility

Mechanicsville, Virginia, 23116, United States

Location

Unknown Facility

Medellín, Colombia

Location

Unknown Facility

Bad Segeberg, Germany

Location

Unknown Facility

Essen, D-45138, Germany

Location

Unknown Facility

Ludwigshafen, Germany

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Eindhoven, 5623 EJ, Netherlands

Location

Results Point of Contact

• Title: Amy Culley, Director of Vascular Intervention
• Organization: BIOTRONIK

amy.culley@biotronik.com

503-451-8034

Study Officials

• Saurabh Gupta, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2017
• Last Updated: September 28, 2018
• Results First Posted: May 30, 2017

Record last verified: 2018-08

Locations

LA (1); NL (2); DE (3); CO (1); US (28)