DARE-trial: A trial studying the effect of the SeQuent Please drug-eluting balloon compared to the Xience Prime drug-eluting stent for the treatment of stenosis of an earlier implanted stent.

DARE-Trial: Drug eluting bAlloon for in-stent REstenosis. Multi-center, randomized trial to study the effect of the SeQuent Please drug-eluting balloon versus the Xience Prime drug-eluting stent for the treatment of in-stent restenosis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29409

Enrollment

270

Registered

2010-01-29

Start date

2010-04-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In-stent restenosis Minimal lumen diameter In-stent restenose Minimale lumen diameter

Interventions

1. PCI with drug-eluting balloon

2. PCI with drug-eluting stent.

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Minimal lumen diameter (MLD) assessed by quantitative coronary angiography (QCA) at 6 months after PCI.	—

Secondary

Measure	Time frame
1. In-stent and in-segment percent Diameter Stenosis (% DS) at 6 months; 2. In-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 6 months; 3. Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm at 6 months; 4. Cardiac death; 5. Myocardial infarction, unless originating from a un-treated vessel; 6. Target vessel revascularization, either by PCI or CABG; 7. Stent thrombosis; 8. Ischemia driven target vessel restenosis, not amenable to revascularization.	—

Measure

Time frame

1. In-stent and in-segment percent Diameter Stenosis (% DS) at 6 months; 2. In-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 6 months; 3. Persisting dissection (i.e. dissection post-index-procedure that remained present at follow-up), thrombosis and aneurysm at 6 months; 4. Cardiac death; 5. Myocardial infarction, unless originating from a un-treated vessel; 6. Target vessel revascularization, either by PCI or CABG; 7. Stent thrombosis; 8. Ischemia driven target vessel restenosis, not amenable to revascularization.

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Contacts

Public ContactJ. Baan

Meibergdreeg 9

J.Baan@amc.uva.nl+31 (0)20 5665685

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)