To evaluate the vascular response to the Sideguard® Coronary Sidebranch Stent in de novo coronary bifurcation lesions using IVUS and OCT.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the change in stent area (mm2) and corresponding vessel area
change (mm2) at the carina of the sidebranch by IVUS assess at 6 months from
the index Sideguard® stent implantation procedure.
Secondary outcome
Device success, lesion success, procedural success, angiography at 6 months,
IVUS at 6 months and/or OCT at 6 months, MACE at 6 months, and stent thrombosis
rate.
Background summary
Self expanding stents are known to generate forces against a vessel wall. The
Sideguard® stent generates low to moderate radial force, and the vascular
system will tend to remodel (enlarge) with time to neutralize this radial
force. IVUS analysis on a small subset of patients has indicated that the
increase in stent area compensated for the intimal hyperplasia response.
Study objective
To evaluate the vascular response to the Sideguard® Coronary Sidebranch Stent
in de novo coronary bifurcation lesions using IVUS and OCT.
Study design
Prospective, multicenter, single arm trial.
Intervention
IVUS pre procedure, followed by implantation of Sideguard® Coronary Sidebranch
Stent, followed by IVUS post procedure. Also IVUS and/or OCT will be carried
out at 6 months follow up.
Study burden and risks
The Sideguard® stent is a CE market product, and hence has proven its safety
and efficacy for its approved indications. Therefore there are no additional
risks for the patient. In addition, the follow up activities will be carried
out in accordance with approved CE marked diagnostic procedures and standard
operating procedures for the centres. Therefore there are no additional risks
for the patient.
Unit 3, Ballybrit Business Park
N/A
IE
Unit 3, Ballybrit Business Park
N/A
IE
Listed location countries
Age
Inclusion criteria
1. Above 18 years of age.
2. Significant ischemic heart disease (CCS class, Braunwald class B, C and I *II, or documented silent ischemia).
3. Treatment of a single bifurcated de novo lesion in a native vessel (Medina type 1,1,1; 1,0,1; 0,1,1).
4. Main vessel lesion in a vessel with a reference vessel diameter (RVD) of 2.8 * 4.0mm and 30 mm in length and a sidebranch lesion with a RVD of 2.25 * 3.25mm and 7mm in length (visual estimate) in patients with single or multi vessel disease.
5. Acceptable candidate for coronary intervention and coronary bypass surgery.
6. The patient has been informed about the trial, agrees to its provisions and provided written informed consent approved by the applicable committee (EC).
7. Target lesion must be <100% occluded by visual estimate (minimum TIMI 2 Flow)
Exclusion criteria
1. Target lesion is a totally occluded main vessel or sidebranch.
2. Target lesion has extensive tortuosity or calcification unsuitable for stent delivery and deployment.
3. Target lesion bifurcation cannot be clearly visualized by angiography (location of ostium border line and the sidebranch angle).
4. Target lesion is located in the left main coronary artery or a RAMUS anatomy.
5. Recent myocardial infarction (either STEMI or Non-STEMI < 72 hours prior to planned index procedure).
6. Angiographic evidence of occlusive thrombus.
7. Ejection fraction < 30%.
8 Impaired renal function (serum creatinine > 2.0mg/dl).
9 Known allergies to aspirin, clopidogrel or ticlopidine, heparin, nitinol, *limus family of compounds*, or taxane compounds.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29804.029.09 |