CClinicalTrials.gg
Status unknownNCT02891005Updated Sep 9, 2016

Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)

A Phase 3 interventional study of paclitaxel controlled release balloon catheter (VasoguardTM) and common balloon catheter (Maverick2) in Small Vessel Lesion, sponsored by Shandong Branden Med.Device Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-09.

Sponsored by Shandong Branden Med.Device Co.,Ltd · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter VasoguardTM in treatment of small vessel lesion.

Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM) Control group: common balloon catheter (Maverick2)

02

Conditions studied

  • Small Vessel Lesion
03

In context

Constriction, Pathologic

1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.

This study's planned enrollment of 230 is above the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

Shandong Branden Med.Device Co.,Ltd is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subject need 18 to 80 years of aged male or non-pregnant women; Subject has stable anina pectoris, or unstable anina pectoris, or old myocardial infarction patients, or ischemia with evidence but without symptom; Subject has a life expectancy of more than 2 years; Lesion vessel reference diameter is less than or equal to 2.5mm, target lesion length is less than or equal to 40mm; Target lesion stenosis is equal or greater than 70% or 50% and with ischemia; Single or two coronary small vessel lesions in situ; Subject can understand the trail purpose, sign informed consent voluntarily, agree to accept clinical telephone follow-up and angiographic follow-up at 9 months; Target lesion can be pre-expanded successfully (Guide wire can get through lesion, balloon pre-expand the remnant stenosis of vessel lumen is less or equal to 50%, without current limiting interlayer and thrombosis).

Exclusion criteria

Exclusion Criteria:

Patient that in the opinion of the investigator is not appropriate for this trail; Pregnancy and lactation female patients; Patient has a life expectancy of less than 2 years; Severe congestive heart failure or NYHA IV heart failure; Patient who have bleeding constitution, cannot use antithrombotic and antiplatelet drugs; Patient that happened acute myocardial infarction within a week; Patient who happened stroke within six months; Patient who with severe renal failure (GFR≤30ml/Min); Patient has received heart transplantation; Patient who cannot tolerate aspirin and / or P2Y12 receptor inhibitor drugs; Patient who has allergy to paclitaxel, PLGA or contrast agent; Peptic ulcer or gastrointestinal bleeding within the prior 6 months; Patients who are participating in another drug or device clinical trail, which have not completed the primary endpoint follow- up period.

Angiographic relevant: Merge three or more coronary small vessel lesions; Target vessel with extensive thrombosis evidence; Restenosis of vein graft after bypass surgery; Target lesion proximal exist seriously distorted or severe calcified lesion.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
230 participants (estimated)

Study arms

  • Experimental
    paclitaxel controlled release balloon catheter

    Patients treated with paclitaxel controlled release balloon catheter

    Device: paclitaxel controlled release balloon catheter (VasoguardTM)

  • Experimental
    common balloon catheter

    Patients treated with common balloon catheter

    Device: common balloon catheter (Maverick2)

Interventions

  • Devicepaclitaxel controlled release balloon catheter (VasoguardTM)

    paclitaxel controlled release balloon catheter implantation for small vessel lesion

  • Devicecommon balloon catheter (Maverick2)

    common balloon catheter implantation for small vessel lesion

06

What researchers measure

Primary outcomes

  1. Late lumen loss

    Time frame: at 9 months

Secondary outcomes

  1. Incidence of Device Success

    Time frame: at 9 months

  2. Incidence of Operation Success

    Time frame: at 9 months

  3. Incidence of the target lesion in-segment restenosis (%) at 9mm

    Time frame: at 9 months

  4. Clinical-driven target lesion revascularization (TLR) and target vessel revascularization (TVR)

    Time frame: at 9 months

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital Fudan University
    Beijing, Beijing 100032, China
    • Junbo Ge · Contact · 13901977506
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02891005
Lead sponsor
Shandong Branden Med.Device Co.,Ltd
Responsible party
Sponsor
First posted
Sep 7, 2016
Start date
Dec 2015
Primary completion
Dec 2017 (estimated)
Last update
Sep 9, 2016

Study contacts

Yuxia Yin
Contact
yinyx@brandentech.com
18596253015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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