Local Paclitaxel or Balloon Angioplasty Below the Knee

Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03149913

Acronym

SAMBA

Enrollment

120

Registered

2017-05-11

Start date

2016-12-15

Completion date

2020-07-31

Last updated

2017-05-11

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

Conditions

Occlusion, Restenosis, Stenosis

Keywords

below the knee artery, endovascular, drug coated balloon, critical limb ischemia

Brief summary

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

Detailed description

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.

Interventions

DEVICESequentPlease OTW paclitaxel coated balloon catheter

PTA with SequentPlease OTW paclitaxel coated balloon catheter

DEVICEconventional uncoated balloon for BTK endovascular therapy

PTA with uncoated balloon for BTK endovascular therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

drug coated balloon versus uncoated balloon

Intervention model description

The vessel patency (measured by angiography at 6 months) will be compared after patients have been treated either with paclitaxel coated or uncoated balloons (control) in BTK arteries

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \>18 years of age * Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries * Rutherford 2-5 patients * Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis) * Lesion length limited to 5-25 cm

Exclusion criteria

* Planned or foreseeable amputation * Previous amputation at the index limb * Index vessel with no run-off to the foot distal to the index lesion * Prior treatment of the index lesion with a drug coated balloon * In-stent restenosis * Life expectancy \<1 year * Known creatinine \>1.4 mg% if patient is not on dialysis * Acute thrombus in the index limb * Aneurysm in the index leg * Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel * Patients with concomitant medical illnesses that require cytostatic or radiation therapy

Design outcomes

Primary

Measure	Time frame	Description
Occlusion rate of the target lesion at 6 months	6 +/- 1 months	by digital substraction angiogram or MRI

Secondary

Measure	Time frame	Description
target lesion revascularization	3, 6, 12 and 24 months	repeat intervention

Other

Measure	Time frame	Description
Wound status	3, 6, 12 and 24 months	improvement, no change, worsening
Walking distance	3, 6, 12 and 24 months	Evaluation of Rutherford category

Countries

Austria, Germany

Contacts

Primary ContactGunnar Tepe, MD

gunnar.tepe@ro-med.de+498031365

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026