First in Man Trial - BIOSOLVE-I
NCT01168830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2015-02-05
Summary
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
Conditions
- de Novo Lesions in Native Coronary Arteries
Interventions
- DEVICE
-
AMS-3.0
Sponsors & Collaborators
-
Biotronik AG
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2011-12-31
- Completion
- 2014-12-31
Countries
- Belgium
- Germany
- Netherlands
- Switzerland
Study Locations
More Related Trials
-
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
NCT02389946 ·Status: COMPLETED ·Phase: NA
-
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System
NCT05540223 ·Status: RECRUITING ·Phase: NA
-
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
NCT01939249 ·Status: UNKNOWN ·Phase: NA
-
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
NCT06779630 ·Status: RECRUITING ·Phase: NA
-
BIOHELIX-I Bare Metal Stent Study
NCT01612767 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold
NCT02916485 ·Status: SUSPENDED ·Phase: NA
-
Vascular Implant Safety and Efficacy Study
NCT03263858 ·Status: COMPLETED ·Phase: NA
-
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
NCT07091682 ·Status: RECRUITING ·Phase: NA
-
MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study
NCT01531725 ·Status: COMPLETED ·Phase: NA
-
ABSORB Clinical Investigation, Cohort B
NCT00856856 ·Status: COMPLETED ·Phase: NA
-
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
NCT04175626 ·Status: COMPLETED
-
Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions
NCT07022587 ·Status: RECRUITING ·Phase: NA
-
SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System
NCT00180453 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System
NCT01788150 ·Status: COMPLETED ·Phase: NA
-
First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis
NCT02236975 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
NCT01638507 ·Status: COMPLETED ·Phase: NA
-
A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
NCT04179045 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The TRIMAXX Coronary Stent Trial
NCT00596661 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions
NCT01760083 ·Status: COMPLETED ·Phase: NA
-
Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation
NCT02176265 ·Status: COMPLETED ·Phase: NA
-
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
NCT01426139 ·Status: COMPLETED ·Phase: NA
-
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
NCT01721096 ·Status: COMPLETED
-
ABSORB STEMI: the TROFI II Study
NCT01986803 ·Status: COMPLETED ·Phase: NA
-
The Medtronic RESOLUTE Clinical Trial
NCT00248079 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
NCT00217256 ·Status: COMPLETED ·Phase: NA