N/A
ID
Bron
Aandoening
In-stent restenosis
Minimal lumen diameter
In-stent restenose
Minimale lumen diameter
Ondersteuning
B. Braun Medical b.v.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI.
Achtergrond van het onderzoek
Background of the study:
Coronary in-stent restenosis is commonly treated by using a drug eluting stent (DES). There are, however, some concerns about the safety of drug eluting stents, in particular with respect to delayed healing, chronic inflammatory reaction, and late or very late stent thrombosis. It is unknown whether the current treatment with another layer of stents may add to the risk of stent thrombosis or reoccurrence of restenosis. Therefore, the relatively new drug-eluting balloons may provide an alternative for treatment of in-stent restenosis, avoiding a double stent layer. The expected advantages of such drug-eluting balloons over stents are the ease of access of the lesion, the absence of a multiple stent layer, and the shorter necessity of the use of dual antiplatelet therapy. Several studies have demonstrated safety and efficacy of the Sequent Please drug-eluting balloon (DEB). Whether the drug eluting balloon is as effective as a drug eluting stent in preventing re-restenosis is
not known.
Objective of the study:
The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.
Study design:
The study is designed as an multi-center, randomized, prospective two-arm trial with either PCI with a drug eluting balloon or a drug eluting stent for in-stent restenosis. Blinded evaluation of endpoints by independent core laboratory.
Study population:
The study population consists of 270 patients ( ≥ 18 years of age) with indication for PCI for in-stent restenosis of whom 135 are randomised to a drug eluting balloon and 135 are randomised to a drug eluting stent. Individuals have signed an infomed consent for study measurements.
Intervention:
PCI with a drug-eluting stent, or PCI with a drug-eluting balloon.
Primary study parameters/outcome of the study:
The primary objective of this study is to determine whether PCI with the SeQuent ® Please DEB versus PCI with the Xience™ Prime DES for the treatment of patients with in-stent restenosis is non-inferior with respect to minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at six months.
Secundary study parameters/outcome of the study:
The secondary study parameters are the following parameters:In-stent and in-segment percent Diameter Stenosis (% DS) at 6 months, in-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 6 months, aneurysm, thrombosis and persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up) at 6 months, cardiac death, myocardial infarction, unless originating from a un-treated vessel, target vessel re-vascularization, either by PCI or CABG,
stent thrombosis, ischemia driven target vessel re-stenosis, not amenable to re-vascularization.
Doel van het onderzoek
N/A
Onderzoeksopzet
30 days, 6 months, 1,2,3,4,5 years.
Onderzoeksproduct en/of interventie
1. PCI with drug-eluting balloon;
2. PCI with drug-eluting stent.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts;
2. Restenosis of any type of stent; all drug-eluting stents or bare metal stents;
3. Restenosis must be present > 50% in-stent and < 5 mm out of the stent. (Annex B);
4. A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation;
5. Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES;
6. Amendable to dual antiplatelet treatment for the duration of 1 year;
7. Patients must be ≥ 18 years of age;
8. Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives;
9. Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month);
10. Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study;
2. Patients have to meet the inclusion criteria;
3. Life expectancy less than one year;
4. Severe renal insufficiency (glomerular filtration rate <30mL/min), with exception of of patients with renal dialysis;
5. STEMI;
6. In-stent re-restenosis already treated with a second stent;
7. Restenosis in a biodegradable stent;
8. Restenosis in a non CE marked stent;
9. Requirement for PCI in the same vessel or expected in the next 6 months.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2072 |
| NTR-old | NTR2189 |
| Ander register | METC AMC : 10/043 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |