An interventional study of Medtronic Coronary Drug-Coated Balloon Catheter in In-stent Restenosis, Ischemic Heart Disease and Coronary Artery Disease, sponsored by Medtronic Vascular. Completed at 10 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment
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Among 46 studies in Coronary Artery Disease by Medtronic — 2 open to participants now, 3 under way, none of them phase 3. Coronary Artery Disease · Medtronic.
Among the 46 studies in Coronary Artery Disease by Medtronic, this one is the 29th largest by enrollment of the 33 interventional ones that give a count, is one of 6 that started in 2017, is one of 28 with no phase, and was the 38th registered.
4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.
Browse Coronary Artery Disease studies →2 of the 46 studies in Coronary Artery Disease by Medtronic are open now, in 12 countries. Recruiting first, the newest first:
Medtronic Vascular · Sites in United States, Canada, Germany and 6 more countries
Ages 18+
Medtronic · Sites in United States, Argentina, Australia and 38 more countries
By country, each count listing its studies:
Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
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46 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 6 started in 2017.
This study's enrollment of 50 is below the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Median enrollment 230 across the 33 interventional studies, 448 across the 13 observational. Of the 43 that completed or were terminated, 20 (47%) have results posted.
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This study is registered under Medtronic Vascular, one of the names counted as Medtronic. Under that name alone:
Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
1 of the studies in Coronary Artery Disease by Medtronic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06535854Medtronic VascularPrevail Global Study | 2027-02 |
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Among the 46 studies in Coronary Artery Disease by Medtronic, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated Balloon Catheter.
Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.
Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.
This study's enrollment of 50 is below the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Compared within Coronary Artery Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Ischemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria
Key Exclusion Criteria
Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.
Device: Medtronic Coronary Drug-Coated Balloon Catheter
Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months
The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.
Time frame: At 6 months follow up
All deaths including cardiac death.procedure
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Time frame: 30 days, 6 months and 1 year after procedure
Target Vessel Myocardial Infarction (TVMI)
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Time frame: 30 days, 6 months and 1 year after procedure
Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
Time frame: 30 days, 6 months and 1 year after procedure
Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
Time frame: 30 days, 6 months and 1 year after procedure
5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Time frame: 30 days, 6 months and 1 year after procedure
All revascularizations (TLR, TVR and non-TVR).
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Time frame: 30 days, 6 months and 1 year after procedure
Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Time frame: 30 days, 6 months and 1 year after procedure
Acute success (device, lesion and procedure success).
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Time frame: 30 days, 6 months and 1 year after procedure
In-stent (balloon) and in-segment LLL
Angiographic Endpoints to be assessed at 6 months post-procedure
Time frame: 6 months post-procedure
In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).
Angiographic Endpoints to be assessed at 6 months post-procedure
Time frame: 6 months post-procedure
In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)].
Angiographic Endpoints to be assessed at 6 months post-procedure
Time frame: 6 months post-procedure
In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD).
Angiographic Endpoints to be assessed at 6 months post-procedure
Time frame: 6 months post-procedure
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Jan 2019, 15 months.
Of 177 industry-sponsored interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's 15 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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