BIOFLOW-VII: Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

Sponsor

Biotronik, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04175626

Collaborator

(none)

556

Enrollment

Locations

71.3

Anticipated Duration (Months)

16.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Atherosclerosis, Coronary Myocardial Ischemia Ischemic Heart Disease Acute Coronary Syndrome Angina Pectoris	Device: Orsiro DES

Detailed Description

BIOFLOW-VII is a prospective, multicenter, single-arm study. Subjects with coronary artery disease (CAD) who undergo an on-label percutaneous coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened post-index procedure per the protocol inclusion and exclusion criteria.

Following the index procedure and study enrollment, subjects will be followed for 5 years. The follow-up schedule will include an intermediate study visit at 1 month, a primary endpoint study visit at 12 months, and long-term study visits at 2, 3, 4, and 5 years.

Study Design

Study Type:

Observational

Actual Enrollment :

556 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

BIOTRONIK - A Prospective Multicenter Study to Confirm the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - VII

Actual Study Start Date :

Jan 24, 2020

Actual Primary Completion Date :

Jan 12, 2022

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Orsiro sirolimus coronary stent system Intervention with a Orsiro DES.	Device: Orsiro DES Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating. Other Names: Orsiro sirolimus coronary stent system

Arm

Intervention/Treatment

Orsiro sirolimus coronary stent system

Intervention with a Orsiro DES.

Device: Orsiro DES

Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.

Other Names:

Orsiro sirolimus coronary stent system

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure [12-Months]
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is ≥18 years of age.
Subject was an acceptable candidate for treatment with a drug eluting stent at the qualifying index procedure, in accordance with the applicable guidelines on percutaneous coronary interventions and manufacturer's Instructions for Use.
Subject received at least one Orsiro stent during an index procedure occurring within 24 hours prior to informed consent, as assessed by the end time of procedure. If more than one stent was implanted during the index procedure, all stents were Orsiro stents.
Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.
Subject is willing to comply with study follow-up requirements.
Subject has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. Legally authorized representatives are not allowed to consent on a subject's behalf.

Each target lesion/vessel must have met all of the following angiographic criteria from the index procedure for the subject to be eligible for the trial:

Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
Target lesion must be in major coronary artery or branch (target vessel).
Target lesion must have angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate). If the target lesion is < 70% stenosed, there should be clinical evidence of ischemia.
Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow > 1.
Target lesion must be ≤ 36 mm in length by operator visual estimate.
Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
Target lesion must have been treated with a maximum of two overlapping stents.

Exclusion Criteria:

Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.
Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), silicon carbide, PLLA, sirolimus.
Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure or any PCI planned within the next 1 year.
Presence of an untreated clinically significant stenosis post-procedure whether treatment is planned or not.
Planned surgery within 6 months of index procedure unless DAPT can be maintained throughout the peri-surgical period.
History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
Subject has documented LVEF < 30% prior to consent.
Subject is dialysis-dependent.
Subject has impaired renal function (blood creatinine > 2.5 mg/dL or 221 μmol/L prior to the index procedure).
Subject has leukopenia (i.e. < 3,000 white blood cells/mm3), thrombocytopenia (i.e. < 100,000 platelets/mm3) or thrombocytosis (i.e. > 700,000 platelet/mm3).
Any significant concurrent medical diagnosis that would potentially impact DAPT effectiveness or increase thrombotic risk.
Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
Subject has life expectancy of < 1 year.
Subject is participating in an investigational (medical device or drug) clinical 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 follow-up requirements of this study or does not involve a drug that may confound the interpretation of any relevant clinical events of interest (e.g. investigational DAPT therapy).
In the investigator's opinion, subject will not be able to comply with the follow-up requirements.

Subjects will be excluded from the trial if any of the target lesions/vessels met any of the following angiographic criteria during the index procedure:

Target lesion was located within or treated through a saphenous vein graft or arterial graft.
Target lesion was a restenotic lesion that was previously treated with a bare metal or drug-eluting stent (in-stent restenosis).
Target lesion had any of the following characteristics:
Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
Involves a side branch of > 2.0 mm in diameter.
Target vessel/lesion was excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
Target vessel had angiographic evidence of thrombus.
Target lesion was totally occluded (100% stenosis).
Target vessel was treated with brachytherapy any time prior to the index procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Associates of Mobile	Fairhope	Alabama	United States	36532
2	John Muir Medical Center	Concord	California	United States	94520
3	St. Joseph Hospital Orange	Orange	California	United States	92868
4	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
5	AdventHealth Tampa	Tampa	Florida	United States	33613
6	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
7	University of Illinois	Chicago	Illinois	United States	60612
8	University of Chicago Medical Center	Chicago	Illinois	United States	60637
9	Advocate Lutheran General Hospital	Park Ridge	Illinois	United States	60068
10	Ascension St. Vincent Medical Group	Indianapolis	Indiana	United States	46920
11	Ascension Via Christi Hospitals	Wichita	Kansas	United States	67226
12	University of Kentucky	Lexington	Kentucky	United States	40536
13	Northern Light Cardiology	Bangor	Maine	United States	04401
14	MedStar Union Memorial Hospital	Baltimore	Maryland	United States	21218
15	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
16	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
17	Baystate Medical Center	Springfield	Massachusetts	United States	01199
18	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
19	Minneapolis Heart Institute	Minneapolis	Minnesota	United States	55407
20	Saint Michael's Medical Center	Newark	New Jersey	United States	07102
21	Maimonides Medical Center	Brooklyn	New York	United States	11219
22	Columbia University Medical Center	New York	New York	United States	10032
23	Weill Cornell Medical College	New York	New York	United States	10065
24	Mercy Health - St Vincent Medical Center	Toledo	Ohio	United States	43608
25	Penn State Health Holy Spirit Medical Center	Camp Hill	Pennsylvania	United States	17011
26	AnMed Health	Anderson	South Carolina	United States	29621
27	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
28	Seton Medical Center Austin	Austin	Texas	United States	78705
29	Austin Heart	Austin	Texas	United States	78756
30	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75226
31	UT Health Science Center	Houston	Texas	United States	77030
32	University of Virginia Health System	Charlottesville	Virginia	United States	22908
33	Charleston Area Medical Center Memorial Hospital	Charleston	West Virginia	United States	25304