Prospective, Randomized, Controlled, Multicentre, Open Study Releas of Paclitaxel during PTA versus PTA alone for the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

Prospective, Randomized, Controlled, Multicentre, Open Study Releas of Paclitaxel during PTA versus PTA alone for the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries. - FREERIDE-STUDY

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35958

Enrollment

Registered

2012-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

narrowing of the bloodvessel stenosis

Interventions

PTA with paclitaxel-eluting PTA balloon Freeway or stenting-PTA or PTA alone.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with symptomatic ischemia, requiring treatment of SFA or popliteal artery

Exclusion criteria

Exclusion criteria: Pregnancy, aneurisma disease of the abdominal aorta, iliac or popliteal arteries, contraindication for anti platelet therapy, stroke

Design outcomes

Primary

Measure	Time frame
Rate of clinically driven target lesion revascularization (TLR) at 6 months	—

Secondary

Measure	Time frame
1. Technical success defined as the rate of successfully performed index procedures after wire passage 2. Late lumen loss, i.e. the difference between the minimum lumen diameter after intervention and during the follow-up at 6 months determined by angiography 3. Clinical success defined as technical success without the occurrence of serious adverse events during procedure 4. Ankle-Brachial Index improvement of >= 0.1 (ABI before procedure compared with ABI at discharge and at 6, 12 (and 24) months 5. Primary and secondary patency rate defined as	—

Measure

Time frame

1. Technical success defined as the rate of successfully performed index procedures after wire passage 2. Late lumen loss, i.e. the difference between the minimum lumen diameter after intervention and during the follow-up at 6 months determined by angiography 3. Clinical success defined as technical success without the occurrence of serious adverse events during procedure 4. Ankle-Brachial Index improvement of >= 0.1 (ABI before procedure compared with ABI at discharge and at 6, 12 (and 24) months 5. Primary and secondary patency rate defined as

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

Prospective, Randomized, Controlled, Multicentre, Open Study Releas of Paclitaxel during PTA versus PTA alone for the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Outcome results