Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT02468960
Status:
UNKNOWN
Last Update Posted:
2017-10-31
First Post:
2015-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
Sponsor:
SIS Medical AG
Organization:
Study Overview
Official Title:
Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold).
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Detailed Description:
Study design:
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
* OPN strategy (study group): pre-dilatation with OPN NC ® Super High Pressure PTCA (Percutaneous Transluminal Coronary Angioplasty) balloons
* standard strategy (control group): pre-dilatation with a standard (compliant) balloon
Enrolment:
Randomization of 50 patients
* 25 in the OPN strategy (study group)
* 25 in the standard strategy (control group)
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
* OPN strategy (study group): pre-dilatation with OPN NC ® Super High Pressure PTCA (Percutaneous Transluminal Coronary Angioplasty) balloons
* standard strategy (control group): pre-dilatation with a standard (compliant) balloon
Enrolment:
Randomization of 50 patients
* 25 in the OPN strategy (study group)
* 25 in the standard strategy (control group)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: