To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

NCT05662618 | Unknown DMC

• 1 other identifier: LFBMA-202201
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• primary patency rate, PPR.

  It is defined as:Primary patency of target lesion: the target lesion is patency (systolic peak blood flow ratio\<2.4) and there is no clinically driven target lesion revascularization (TLR) by Doppler ultrasound.

  12months

Secondary Outcomes (3)

• Device success rate

  The day of operation.

• Operation success rate

  1DAY

• Target Lesion Revascularization incidence.

  12 months after operation.

Other Outcomes (2)

• Incidence rate of major adverse events

  12 months after operation.

• Occurrence of other adverse events and serious adverse events

  12 months after operation.

Study Arms (2)

Rapamycin coated peripheral balloon catheter

EXPERIMENTAL

Rapamycin coated peripheral balloon catheter of Bomaian Company.

Procedure: Percutaneous selective arteriography of peripheral arteries

Drug eluting peripheral balloon catheter

ACTIVE COMPARATOR

Paclitaxel eluting balloon catheter

Procedure: Percutaneous selective arteriography of peripheral arteries

Interventions

Percutaneous selective arteriography of peripheral arteries PROCEDURE

Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.

Drug eluting peripheral balloon catheter; Rapamycin coated peripheral balloon catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.
• Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
• Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)

You may not qualify if:

• This operation is planned to intervene patients with bilateral lower limbs.
• Patients whose guide wire fails to pass through the target lesion.
• Patients whose target lesion is in stent restenosis (ISR).
• ≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion).
• Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.
• Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).
• There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis\<50%).
• Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.
• Patients with obviously abnormal renal function (creatinine \> 2.5mg/dL or 220umol/L) or undergoing dialysis.
• Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.
• Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.
• Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.
• Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.
• Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.
• Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.

Sponsors & Collaborators

• Shanghai Bomaian Medical Technology Co., Ltd: lead

Study Sites (1)

The First Medical Center of the General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Wei Guo

CONTACT

010-66887329; Pla301dml@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 22, 2022
• Study Start: December 31, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)