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

Coronary Artery Disease Clinical Trial

— BIOFLOW-VII  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04175626
• Other study ID #: BIOFLOW-VII
• Status: Active, not recruiting
• Start date: January 24, 2020
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 556
• Est. completion date: January 2026
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is =18 years of age.

2. 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.

3. 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.

4. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.

5. Subject is willing to comply with study follow-up requirements.

6. 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:

1. 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).

2. Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.

3. Target lesion must be in major coronary artery or branch (target vessel).

4. 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.

5. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow > 1.

6. Target lesion must be = 36 mm in length by operator visual estimate.

7. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.

8. Target lesion must have been treated with a maximum of two overlapping stents.

Exclusion Criteria:

1. Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.

2. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.

3. 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.

4. 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.

5. Presence of an untreated clinically significant stenosis post-procedure whether treatment is planned or not.

6. Planned surgery within 6 months of index procedure unless DAPT can be maintained throughout the peri-surgical period.

7. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.

8. Subject has documented LVEF < 30% prior to consent.

9. Subject is dialysis-dependent.

10. Subject has impaired renal function (blood creatinine > 2.5 mg/dL or 221 µmol/L prior to the index procedure).

11. 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).

12. Any significant concurrent medical diagnosis that would potentially impact DAPT effectiveness or increase thrombotic risk.

13. Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).

14. Subject has life expectancy of < 1 year.

15. 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).

16. 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:

1. Target lesion was located within or treated through a saphenous vein graft or arterial graft.

2. Target lesion was a restenotic lesion that was previously treated with a bare metal or drug-eluting stent (in-stent restenosis).

3. Target lesion had any of the following characteristics:

1. 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).

2. Involves a side branch of > 2.0 mm in diameter.

4. 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.

5. Target vessel had angiographic evidence of thrombus.

6. Target lesion was totally occluded (100% stenosis).

7. Target vessel was treated with brachytherapy any time prior to the index procedure.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Atherosclerosis
• Atherosclerosis, Coronary
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	AnMed Health	Anderson	South Carolina
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	Seton Medical Center Austin	Austin	Texas
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Northern Light Cardiology	Bangor	Maine
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Penn State Health Holy Spirit Medical Center	Camp Hill	Pennsylvania
United States	Charleston Area Medical Center Memorial Hospital	Charleston	West Virginia
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	John Muir Medical Center	Concord	California
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Cardiology Associates of Mobile	Fairhope	Alabama
United States	UT Health Science Center	Houston	Texas
United States	Ascension St. Vincent Medical Group	Indianapolis	Indiana
United States	University of Kentucky	Lexington	Kentucky
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	St. Joseph Hospital Orange	Orange	California
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Baystate Medical Center	Springfield	Massachusetts
United States	AdventHealth Tampa	Tampa	Florida
United States	Mercy Health - St Vincent Medical Center	Toledo	Ohio
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Ascension Via Christi Hospitals	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure	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).	12-Months
Secondary	All-cause Death		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Protocol-defined Any-vessel Myocardial Infarction		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Target Lesion Revascularization (TLR)		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Target Vessel Revascularization (TVR)		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Cardiac Death or Protocol-defined Any-vessel MI		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR		at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Secondary	Stent Thrombosis		at 24 Hours, at 1 Month, at 1 Year
Secondary	Number of Lesions With Device Success	Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only.	at Hospital Discharge an average of 1 day
Secondary	Number of Lesions With Lesion Success	Defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method.	at Hospital Discharge an average of 1 day
Secondary	Number of Participants With Procedure Success	Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).	at Hospital Discharge an average of 1 day