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

NCT01811927 | Terminated DMC

• 1 other identifier: C1210
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss

  9-months post procedure

Study Arms (1)

PRO-Kinetic Energy Stent

EXPERIMENTAL

PRO-Kinetic Energy Stent

Device: PRO-Kinetic Energy Stent

Interventions

PRO-Kinetic Energy Stent DEVICE

Bare-metal stent

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 \> 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
• 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

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.
• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (3)

St. Antonius Hospital

Nieuwegein, 3435, Netherlands

Location

University Hospital of Basel

Basel, 4031, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Christoph Kaiser, Prof

  University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

NL (1); CH (2)