To evaluate the clinical safety and efficacy of the Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In-stent (in balloon) Late lumen loss (LLL) at 6 months post-procedure as
measured by quantitative coronary angiography (QCA).
Secondary outcome
1. All deaths including cardiac death.
2. Target Vessel Myocardial infarction (TVMI).
3. Major adverse cardiac event (MACE) defined as composite of death, myocardial
infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat
target lesion revascularization (clinically driven) by percutaneous or surgical
methods.
4. Target vessel failure (TVF) defined as cardiac death, target vessel
myocardial infarction, or clinically-driven target vessel revascularization
(TVR) by percutaneous or surgical methods.
5. Target lesion failure (TLF) defined by a composite of cardiac death, target
vessel myocardial infarction, or clinically-driven target lesion
revascularization (TLR) by percutaneous or surgical methods.
6. All revascularizations (target lesion revascularization (TLR), target vessel
revascularization (TVR) and non-TVR).
7. Stent Thrombosis rate as defined as definite, probable, possible, and
overall stent thrombosis (according to Academic Research Consortium (ARC)
definition).
8. Acute success (device, lesion and procedure success).
Angiographic Endpoints:
Angiographic parameters to be assessed at 6 months post-procedure including:
1. In-stent (balloon) and in-segment LLL
2. In-stent (balloon) and in-segment percent diameter stenosis (%DS).
3. In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate
[defined as *50% diameter stenosis (DS)].
4. In-stent (balloon) and in-segment Minimal luminal diameter (MLD).
Background summary
To evaluate the clinical safety and efficacy of a new Medtronic Coronary
Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel
disease or ISR with coronary lesions previously treated with drug-eluting or
bare metal stents in native coronary arteries.
Study objective
To evaluate the clinical safety and efficacy of the Drug-Coated Balloon
Catheter in the treatment of de novo lesions, small vessel disease or ISR with
coronary lesions previously treated with drug-eluting or bare metal stents in
native coronary arteries.
Study design
This is a prospective, multicenter, single-arm study with up to 50 subjects
enrolled in up to 15 qualified centers in- and outside of Europe. The
enrollment period is anticipated to be approximately 8 months. Subjects will
remain in the study and continue with follow-up clinical assessments through 12
months, study exit, or death, whichever comes first.
Intervention
A PTCA will be performed with the Medtronic drug-coated ballon to evaluate the
safety and efficacy.
Study burden and risks
Patients may not have immediate medical benefits. The information obtained from
this research may be beneficial to other patients with coronary artery disease
in the future.
Since the Medtronic Coronary Drug-coated Balloon Catheter is an investigational
device, the risks are not entirely known but are believed to be the similar to
those that are associated with the standard, customary angioplasty with a
commercially available drug-coated balloon of a stenosed coronary artery. The
risks associated with using this device are related to the drug, and risks
associated with standard percutaneous coronary diagnostic and treatment
procedures.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
- Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
- Subject is an acceptable candidate for treatment with a Drug-Coated Coranary Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer*s Instructions for Use and the Declaration of Helsinki.
- Successful pre-dilatation of the (entire) target lesion(s) that will be treated with the investigational device. Success being documented by angiographic visual estimate of <30% residual stenosis of the target lesion and no major (> Grade B) flow-limiting dissection.
- Subject has a life expectancy >1 year in the Investigator*s opinion.
- Subject is willing and able to cooperate with study procedures and required follow up evaluations.
Angiographic Inclusion:
- The patient requires treatment of either:
A. At least a single lesion* amenable to treatment with the Medtronic Coronary Drug-Coated Balloon (* if two lesions can be treated by one Drug-Coated Balloon covering both lesions, it will be considered as a single target lesion).
OR
B. A maximum of four lesions in a maximum of 3 vessels. In case 3 vessels require to be treated, at least one should receive a non-DCB treatment, i.e. treatment with a Drug Eluting Stent (DES); this will be called a non-target lesion. Lesions (max. 3) treated with the DCB are considered target lesions.
Note: For subjects with a planned treatment of two to four lesions, the first lesion must be treated successfully and the subject must be clinically stable before treatment of the following one to three lesions are attempted. The lesion(s) in each vessel that is (/are) planned to be treated with the DES should be treated first.
- Target lesion(s) must be * 25 mm in length.
- Target lesion(s) must have a stenosis of * 50% and < 100%.
- Target lesion(s) to be treated with the investigational device must have an RVD between 2.0 and 4.0 mm in diameter.
- Target vessel(s) must have a thrombolysis in myocardial infarction (TIMI) flow * 2.
Note: Measurements may be made by careful visual estimate, on-line QCA, IVUS, or OCT
Exclusion criteria
- Known hypersensitivity or contraindication to aspirin; heparin; bivalirudin; clopidogrel; prasugrel; ticagelor and structurally related compounds; or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative.
- Platelet count < 100,000 cells/mm³ (i.e. 100 x 109/L) or > 700,000 cells/mm³ (i.e. 700 x 109/L), or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to index procedure.
- Serum creatinine level > 2.5 mg/dl (i.e. 221 *mol/L) within 7 days prior to index procedure
- Evidence of an Acute Myocardial Infarction within the previous 72 hours of the study procedure.
- Planned treatment of the left main coronary artery, internal mammary artery, aorto-ostial, and sapheneous vein grafts with the investigational device.
- Planned treatment of more than one lesion in one target vessel, or more than two lesions in two target vessels.
- Planned treatment involves a bifurcation.
- Previous percutaneous coronary intervention (PCI) of the target vessels(s)
- within 3 months prior to the procedure for In-Stent Restenosis;
- within 9 months prior to the procedure for de novo lesions.
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 6 months post-procedure.
- During the index procedure, the target lesion(s) require(s) treatment with a cutting/scoring balloon, atherectomy, laser, or thrombectomy procedure.
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months (any prior stroke or TIA, if prasugrel is used).
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Any previous treatment of the target vessel for restenosis, including brachytherapy.
- Pregnant or breast-feeding woman.
- Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation, within 3 months.
Angiographic Exclusion Criteria
- Target lesion(s) is/are located in a bypass graft (including but not limited to saphenous vein graft or a left/right internal mammary artery.
- Target vessel(s) has/have other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
- Target vessel(s) has/have evidence of thrombus.
- Target vessel(s) is/are excessively tortuous (any bend >90º to reach the target lesion).
- Target lesion(s) has/have any of the following characteristics:
a. Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the left anterior descending (LAD) or left circumflex (LCX)
b. Involves a side branch >2.0mm in diameter
c. Is at a >45º bend in the vessel
d. Is severely calcified
- Unprotected left main coronary artery disease is present (an obstruction greater than 50% in the left main coronary artery).
- Lesion that is planned to be treated is longer than 25 mm in length or RVD is smaller than 2 mm.
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 |
|---|---|
| ClinicalTrials.gov | NCT03260517 |
| CCMO | NL62055.100.17 |