Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02176265
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2014-06-25
Brief Title:
Qvanteq Bioactive Coronary Stent System First in Man FIM Clinical Investigation
Sponsor:
Qvanteq AG
Organization:
Qvanteq AG
Study Overview
Official Title:
Qvanteq Bioactive Coronary Stent System First in Man FIM Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
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:
Objective of this First in Man study is to assess feasibility and safety of Qvanteqs bioactive coronary stent for treatment of stable coronary artery disease patients with de novo coronary artery stenosis in native vessels
The proprietary surface of Qvanteqs bioactive coronary stent improves the in-growth behavior of the stent in the treated vessel In-vivo animal studies revealed fast in-growth similar to BMS which however is not resulting in excessive tissue overgrowth as observed in BMS but rather has an efficacy profile similar to drug-eluting stent DES meaning suppression of tissue overgrowth This should reduce the risk of restenosis and thrombus formation despite the presence of a short term dual anti platelet therapy DAPT Furthermore prolonged DAPT time as applied with current DES increases the bleeding risk of patients
The study is a prospective multicenter open-label single arm study conducted in up to 6 cardiology centers in CH and NL In total approx 35 patients will be enrolled All patients will be treated with the Qvanteqs bioactive coronary stent Clinical follow-up will occur at 1 6 12 months post-stent implantation All patients will undergo angiography assessment QCA and Optical Coherence Tomography investigation OCT at baseline and at 6 months follow-up Baseline OCT should be performed after the successfully completed angiographic procedure documentary OCT 1 and 12 months clinical follow-ups are conducted via telephone
Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months assessed by off-line QCA Primary OCT endpoint is mean neointimal thickness at 6 months assessed by off-line OCT analysis
The proprietary surface of Qvanteqs bioactive coronary stent improves the in-growth behavior of the stent in the treated vessel In-vivo animal studies revealed fast in-growth similar to BMS which however is not resulting in excessive tissue overgrowth as observed in BMS but rather has an efficacy profile similar to drug-eluting stent DES meaning suppression of tissue overgrowth This should reduce the risk of restenosis and thrombus formation despite the presence of a short term dual anti platelet therapy DAPT Furthermore prolonged DAPT time as applied with current DES increases the bleeding risk of patients
The study is a prospective multicenter open-label single arm study conducted in up to 6 cardiology centers in CH and NL In total approx 35 patients will be enrolled All patients will be treated with the Qvanteqs bioactive coronary stent Clinical follow-up will occur at 1 6 12 months post-stent implantation All patients will undergo angiography assessment QCA and Optical Coherence Tomography investigation OCT at baseline and at 6 months follow-up Baseline OCT should be performed after the successfully completed angiographic procedure documentary OCT 1 and 12 months clinical follow-ups are conducted via telephone
Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months assessed by off-line QCA Primary OCT endpoint is mean neointimal thickness at 6 months assessed by off-line OCT analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None