Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent (BIOFLOW-IV)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01939249 |
|
Recruitment Status : Unknown
Verified June 2017 by Biotronik AG.
Recruitment status was: Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : June 26, 2017
|
Sponsor:
Biotronik AG
Information provided by (Responsible Party):
Biotronik AG
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Device: Abbott Laboratories Xience Device: Biotronik Orsiro | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 585 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV |
| Study Start Date : | September 2013 |
| Actual Primary Completion Date : | March 23, 2016 |
| Estimated Study Completion Date : | January 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Abbott Laboratories Xience
Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
|
Device: Abbott Laboratories Xience |
|
Experimental: Biotronik Orsiro
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
|
Device: Biotronik Orsiro |
Primary Outcome Measures :
- Target Vessel Failure [ Time Frame: 12 months post index procedure ]
Secondary Outcome Measures :
- Rate of clinically-driven target lesion revascularization (TLR) [ Time Frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year ]
- Rate of clinically-driven target vessel revascularization (TVR) [ Time Frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year ]
- Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR [ Time Frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Subject must provide written informed consent
- The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA.
- Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent
- Single de novo lesion with ≥ 50% and < 100% stenosis in up to 2 coronary arteries
Main Exclusion Criteria:
- Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
- Planned intervention of non-target vessel(s) within 30 days after the index procedure
- Planned intervention of target vessel(s) after the index procedure
- Target lesion is located in the left main
- Target lesion is located in or supplied by an arterial or venous bypass graft
- Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online QCA
- Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939249
Locations
Show 45 study locations
Sponsors and Collaborators
Biotronik AG
Investigators
| Principal Investigator: | Shigeru Saito, MD | Okinawa Tokushukai Shonan Kamakura General Hospital | |
| Principal Investigator: | Ton Slagboom, MD | Onze Lieve Vrouwe Gasthuis |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biotronik AG |
| ClinicalTrials.gov Identifier: | NCT01939249 |
| Other Study ID Numbers: |
C1204 |
| First Posted: | September 11, 2013 Key Record Dates |
| Last Update Posted: | June 26, 2017 |
| Last Verified: | June 2017 |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |